Evidence summary

NICE has identified studies and reviews relevant to IVL for calcified coronary arteries during PCI from the medical literature. Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion.

Population and studies description

This interventional procedure overview is based on about 4,300 people from 2 systematic reviews and meta-analyses (Sagris, 2024; Caminiti, 2023), 4 prospective studies (Cubero-Gallego, 2022; Aziz, 2020; Rodriguez-Leor, 2024; Aksoy, 2019), and 2 retrospective cohort studies (Wiens, 2021, Rola, 2022). There was significant overlap between the studies included in the meta-analyses. Among the included studies, IVL was the main intervention including some comparator interventions. This is a rapid review of the literature, and a flow chart of the complete selection process is shown in figure 1. This overview presents 8 studies as the key evidence in table 2 and table 3, and lists other relevant studies in appendix B, table 5. Table 2 presents study details.

The key evidence includes explicit comparisons between IVL and other procedures used for treating calcified coronary lesions. This is the reason for including several meta-analyses even if some or all studies overlap. The systematic review and meta-analysis by Sagris (2024) included 38 studies comparing IVL for lesion preparation before stent implantation. The systematic review and meta-analysis by Caminiti (2023) included 13 studies focusing on IVL for treating underexpanded stents.

The review by Sagris (2024) involved 2,977 people, predominantly men, with heavily calcified coronary lesions, with comorbidities such as hypertension, diabetes mellitus, hyperlipidaemia, chronic kidney disease, and previous MI and PCI. Similarly, Caminiti (2023) focused on 354 people with underexpanded coronary stents, also predominantly men and with a high mean age.

The prospective studies, such as those by Cubero-Gallego (2022) and Aziz (2020), provided detailed insights into the procedural success and long-term outcomes of IVL. These studies included people with significant comorbidities and varying clinical presentations, such as acute coronary syndromes and multivessel disease.

The retrospective cohort study by Wiens (2021) added a real-world perspective, focusing on 50 people with highly calcified lesions, including those with ACS, stent failure, and left main coronary artery lesions.

Figure 1 Flow chart of study selection

Table 2 Study details

Study no.

First author, date

country

Characteristics of people in the study (as reported by the study)

Study design

Inclusion criteria

Intervention

Follow up

Sagris M, 2024

2977 patients with heavily calcified coronary lesions.

Mean age: 72.2 plus or minus 9.1 years.

Majority were men (77.5%).

Comorbidities included hypertension, diabetes mellitus, hyperlipidaemia, chronic kidney disease, and previous myocardial infarction and PCI.

Multicentre systematic review and meta-analysis.

Prospective/retrospective analyses of patients undergoing IVL before stent implantation.

Studies reporting short- and/or late-outcomes.

Studies published up to February 23, 2023.

IVL for lesion preparation before stent implantation.

69% of procedures used radial artery access and 32% used the femoral artery.

In-hospital and 30-day follow-up.

Caminiti R, 2023 Italy

354 patients with under expanded coronary stents due to calcified plaques. Mean age: 71.3 years. 77% males.

Systematic review and meta-analysis

Studies reporting on IVL for under expanded stents

IVL for stent under expansion treatment

Mean follow-up of 2.6 months

Wiens EJ, 2021 Canada

50 patients with highly calcified coronary lesions. Median age: 71.5

Majority were men (64%). Comorbidities included ACS, stent failure, and left main coronary artery lesions.

Retrospective cohort study

Patients undergoing IVL for calcified lesions. Real-world settings.

IVL for treatment of calcified coronary lesions.

In-hospital and 30-day follow-up.

Rola P 2022

44 patients in-hospital

Retrospective evaluation

Patients with calcified lesions who had undergone PCI, and who required additional lesion preparation with rotational atherectomy or IVL

IVL

In hospital and 6 months follow-up

Cubero-Gallego H, 2022

Spain

109 patients with 128 calcified coronary lesions. Mean age: 74 years. High rates of comorbidities including diabetes (58%), renal insufficiency (32%), multivessel disease (76%).

Real-world registry.

Prospective, multicentre, single-arm study

Patients >18 years old with severe stenosis and severe calcified coronary lesions in vessels with diameter ≥2.5 mm.

CL for treating calcified coronary lesions.

In-hospital, 30-day follow-up, and long-term follow-up (median of 20 months [IQR, 14.5-25]).

Aziz A, 2020, European Study

190 patients with 200 calcified coronary lesions. Mean age: 72 years. High rates of comorbidities including diabetes (50%) and chronic kidney disease (16%). Acute-coronary syndrome in 48% of cases.

Prospective, multicentre, single-arm study

All patients had treatment with IVL between November 2018 and February 2020 at 6 centres.

IVL for treating calcified coronary lesions.

Median follow-up of 222 days.

Rodriguez-Leor, 2024, Spain

426 patients with calcified coronary lesions. High prevalence of hypertension, diabetes, dyslipidaemia, and prior myocardial infarction (MI) and percutaneous coronary intervention (PCI).

Prospective, multicentre, single-arm, open-label conducted in 26 hospitals

Patients with calcified coronary artery disease requiring PCI and deemed necessary for coronary IVL

Exclusion criteria: refusal to participate, life expectancy <1 year or haemodynamic instability with Killip class III or IV

IVL with coronary IVL system

30 days

Aksoy A, 2019, Germany and Spain

71 patients with 78 calcified coronary lesions. Mean age: 76 (9.7 years range). High prevalence of male sex (71.8%) and comorbidities including hypertension (92.9%), hypercholesterolemia (63.4%), and diabetes (33.8%).

Prospective, observational, multicentre registry

Patients with significant coronary lesions and angiographically graded moderate or severe calcification.

IVL using the Shockwave C2 balloon

In-hospital, 30-day, and ongoing 12-month follow-up

**Table 3 Study outcomes**
First author, date	Efficacy outcomes	Safety outcomes
Sagris M, 2024, Multi-centre	Overall clinical success rate of 93% (95% CI: 91%−95%). Procedural success rate of 97% (95% CI: 95%−98%). There was a significant increase in vessel diameter immediately after IVL application (SMD: 2.47, 95% CI: 1.77−3.17, I² = 96%) and a decrease in diameter stenosis (SMD: −3.44, 95% CI: −4.36 to −2.52, I² = 97.5%). Further reduction in diameter stenosis (SMD: −6.57, 95% CI: −7.43 to −5.72, I² = 95.8%) and an increase in vessel diameter (SMD: 4.37, 95% CI: 3.63−5.12, I² = 96.7%) and calculated lumen area (SMD: 3.23, 95% CI: 2.10−4.37, I² = 98%) were observed after stent implantation. Stenosis, diameter, and lumen area improvements were maintained after stent implantation. Meta-regression analysis showed no significant effect of baseline characteristics on the outcomes.	In-hospital and 30-day MACE incidence was 8% (95% CI: 6%−11%, I² = 84.5%). Myocardial infarction incidence was 5% (95% CI: 2%−8%, I² = 85.6%). Mortality rate was 2% (95% CI: 1%−3%, I² = 69.3%). Periprocedural complications were rare: perforations (1%), dissections (2%), slow flow (0%), or no-reflow phenomena (0%).
Caminiti R, 2023	The study evaluated the efficacy of intravascular lithotripsy (IVL) therapy on 360 treated lesions, with the left anterior descending artery being the most involved vessel (45.9%, 95% CI 36.6% to 55.3%), followed by the right coronary artery (31.8%, 95% CI 24.5% to 39.5%), left circumflex artery (10%, 95% CI 6% to 14.6%), and left main artery (7.9%, 95% CI 4.3% to 12.2%). Lesion preparation before IVL therapy involved noncompliant balloon pre dilatation in 82.6% (95% CI 69.6% to 93%) of patients and the use of a very high–pressure balloon in 29.8% (95% CI 12.2% to 50.5%). Post dilatation following IVL was performed in 83.8% (95% CI 75% to 91.2%) of patients. During the IVL procedure, the mean IVL balloon diameter was recorded at 3.4 mm (95% CI 3.2 to 3.5), with an average of 70.9 lithotripsy pulses (95% CI 62.2 to 79.6) and a mean maximum balloon pressure of 5.2 atmospheres (95% CI 4.3 to 6.2). Intravascular ultrasound imaging was utilized in 33.1% (95% CI 20.1% to 47.4%) of patients, while optical coherence tomography was performed in 23.7% (95% CI 10.9% to 39%). The mean follow-up period was 2.6 months (95% CI 1 to 15.3). Post-IVL outcomes showed significant improvements: the average minimal stent area increased from a baseline value of 3.4 mm² (95% CI 3 to 3.8) to 6.9 mm² (95% CI 6.5 to 7.4). The percent diameter stenosis, assessed by quantitative coronary analysis, reduced from 69.4% at baseline (95% CI 60.7 to 78.2) to 14.6% post-IVL therapy (95% CI 11.1 to 18). Additionally, the mean minimum luminal diameter increased from 1.1 mm (95% CI 0.8 to 1.4) pre-IVL to 2.9 mm (95% CI 2.6 to 3.2) post-IVL. The primary efficacy endpoint, procedural success, was reported in 12 studies with a total of 342 lesions undergoing IVL, achieving success in 289 lesions (88.7%, 95% CI 82.3 to 95.1). Meta-regression analysis suggested a negative influence of left main lesions on procedural success (β −0.91 [−1.46 to −0.37], p = 0.001), while predilatation with OPN showed a positive influence (β 0.27 [0.02 to 0.53], p = 0.035). The heterogeneity for these outcomes was high (I² = 75.7%).	Procedural complications and major adverse cardiac events (MACEs) were reported across 13 studies, with a pooled procedural complications rate of 1.6% (95% CI 0.3 to 2.9). Specific complications included two cases of dissection (types D and F), one perforation (Ellis type III), and one periprocedural myocardial infarction due to IVL balloon rupture. The heterogeneity for these complications was low (I² = 0%), indicating consistent findings.
Wiens EJ, 2021	Angiographic success in 98% of patients (residual stenosis <50%, TIMI 3 flow). >90% of patients were free of angina at 30 days.	In-hospital mortality unrelated to IVL: 3 patients. No occurrences of MACE up to 30 days. Rare complications: no cases of distal embolisation, coronary perforation, or dissection.
Rola P, 2022	High procedural success rates in both groups.	Both techniques were found to be safe with no significant differences in complications.
Cubero-Gallego H, 2022	Procedural success rate of 99% in treating calcified coronary lesions using CL. Patients showed clinical improvements, including enhanced left ventricular ejection fraction and better Canadian Cardiovascular Society angina class, with 78% of patients in class 0–I at long-term follow-up. The long-term follow-up, with a median duration of 20 months, revealed a MACE rate of 5.6%. Additionally, the target-lesion revascularisation (TLR) rate was 1.85%, suggesting effective maintenance of vessel patency and low rates of restenosis in this high-risk population.	CL was characterised by minimal procedural complications. In-hospital and 30-day follow-up data showed a freedom from MACE rate of 98%, with a few instances of coronary dissection, all managed with stenting. There were no reports of slow-flow/no-reflow phenomena, coronary perforation, or target-lesion failure. Long-term follow-up indicated a cardiac death rate of 3.7% and an all-cause death rate of 15%, reflecting the advanced age and comorbidities of the study population. The low TLR rate and absence of significant adverse events, such as stent thrombosis or major bleeding, further support the safety of CL in managing calcified coronary lesions in a high-risk, unselected patient cohort.
Aziz A, 2020	Procedural success in 99% of cases.	MACE rate at median follow-up of 222 days was 2.6%. Rare complications: 2 cases of cardiac deaths (1%), 1 case of target vessel MI (0.5%), and 3 cases of target lesion revascularisation (1.5%).
Rodriguez-Leor, 2024	The procedural success rate for IVL delivery was 99%. The primary efficacy endpoint, defined as successful PCI with residual stenosis less than 20% and no in-hospital MACE, was achieved in 66% of patients. There were no significant differences in angiographic success between patients with CCS and those with ACS, indicating that IVL effectively facilitated stent implantation in severely calcified lesions across different patient subsets.	The primary safety endpoint, defined as freedom from MACE at 30 days, was observed in 96.4% of patients. The overall 30-day MACE rate was 3%, with a higher, though not statistically significant, incidence in ACS patients compared to CCS patients (5% vs. 1%, P=0.073). In-hospital complications included a 0.7% incidence of coronary perforation and a 2.4% incidence of coronary dissection, all of which were managed successfully. There were 7 deaths (1.7%) within 30 days, with 4 being cardiovascular-related. Additionally, 3 cases of stent thrombosis (1.1%) occurred, all in ACS patients. These findings suggest that IVL is associated with a low complication rate in a real-world setting, even among high-risk patients with complex coronary lesions.
Aksoy A, 2019	The primary efficacy endpoint, defined as successful stent delivery with less than 20% residual stenosis, was achieved in 78.2% of the lesions. Specifically, success rates were 84.6% for primary IVL (de-novo lesions), 77.3% for secondary IVL (failed high-pressure balloon dilatation), and 64.7% for tertiary IVL (in-stent restenosis due to under expanded stents). Mean minimal lumen diameter (MLD) increased from 1.01 (range of 0.49 mm) at baseline to 2.88 (range of 0.56 mm) after stenting, indicating effective lesion preparation and improved stent expansion across all groups.	The primary safety endpoint, which included procedural complications and in-hospital MACE, reported no in-hospital MACE in the entire cohort. Procedural complications were low, with 4 type B dissections and seven balloon ruptures occurring without further adverse outcomes. The overall rate of device-related complications was minimal, demonstrating a favourable safety profile for IVL in treating severely calcified coronary lesions. This study indicates that IVL is a feasible and safe method for lesion preparation, with high success rates and low procedural complications in a diverse patient population.

Procedure technique

Of the 8 studies, all detailed the procedure technique and devices used. The most common approach involved the use of IVL for lesion preparation before stent implantation. The technique was consistent across the studies, with minor variations in balloon size and pressure settings based on the severity of the calcification and specific vessel characteristics. The primary device used for IVL was the Shockwave C2 balloon catheter, which delivers pulsatile sonic pressure waves to fracture the calcified plaque and improve vessel compliance.

Efficacy

Procedural and clinical success

Procedural success rate

The procedural success rate, defined as the completion of the procedure with full expansion of the balloon or stent with residual stenosis of less than 30%, or both, and TIMI III flow without any serious angiographic complications, was reported in 6 studies and ranged from 96% to 99%.

Clinical success rate

The clinical success rate, defined as the ability of IVL to achieve a residual stenosis of less than 50% after stent implantation and freedom from major adverse cardiovascular events (MACE), was reported in several studies. Sagris (2024) reported an overall clinical success rate of 93% (95% CI 91% to 95%). Cubero-Gallego (2022) reported a clinical success rate of 99%, and Wiens (2021) noted that over 90% of people were free of angina at 30 days, suggesting a high rate of clinical success.

Vessel diameter and stenosis

Vessel diameter increase

The increase in vessel diameter, measured by the change before and after IVL application and typically reported as a standardised mean difference (SMD), was reported in several studies. Sagris (2024) found a significant increase in vessel diameter (SMD 2.47, 95% CI 1.77 to 3.17, I² = 96%) and a decrease in diameter stenosis (SMD −3.44, 95% CI −4.36 to −2.52, I² = 97.5%) immediately after IVL application. Caminiti (2023) reported a mean increase in minimal luminal diameter from 1.1 mm (95% CI 0.8 to 1.4 mm) pre-IVL to 2.9 mm (95% CI 2.6 to 3.2 mm) post-IVL. Aksoy (2019) also found a significant increase in vessel diameter following IVL, with mean minimal lumen diameter increasing from 1.01 mm at baseline to 2.88 mm after stenting.

Diameter stenosis reduction

The reduction in diameter stenosis, assessed by the percentage reduction in vessel stenosis following IVL and stent implantation, was reported in several studies. Sagris (2024) found a statistically significant reduction in diameter stenosis (SMD −3.44, 95% CI −4.36 to −2.52, I² = 97.5%). Cubero-Gallego (2022) reported a mean reduction in diameter stenosis of 17.5%. Aksoy (2019) also reported a significant reduction in diameter stenosis, with a mean reduction of 17.5%. Caminiti (2023) reported a reduction in diameter stenosis from 69.4% (95% CI 60.7% to 78.2%) pre-IVL to 14.6% (95% CI 11.1% to 18%) post-IVL.

Safety

Major adverse cardiovascular events (MACE)

Major adverse cardiovascular events (MACE), defined as the composite of death, myocardial infarction (MI), and target-vessel revascularisation within a specified follow-up period, were reported in 6 studies. Sagris (2024) reported an in-hospital and 30-day MACE incidence of 8% (95% CI 6% to 11%). Caminiti (2023) reported a pooled MACE rate of 11%. Cubero-Gallego (2022) found a 30-day MACE rate of 2%, with a long-term MACE rate of 5.6% at a median follow-up of 20 months. Aziz (2020) reported a MACE rate of 2.6% at a median follow-up of 222 days. Rodriguez-Leor (2024) found a 30-day MACE rate of 3%, with a higher incidence in people with ACS than in people with CCS (5% vs. 1%, p=0.073). Aksoy (2019) reported no in-hospital MACE in their cohort. Rola (2022) found no statistically significant differences in MACE between RA and S-IVL groups.

Myocardial infarction

The incidence of MI during or after the procedure, assessed within the follow-up period, was reported in several studies. Sagris (2024) reported an MI incidence of 5% (95% CI 2% to 8%). Caminiti (2023) reported a target vessel MI rate of 3%. Cubero-Gallego (2022) included MI within the overall MACE but did not report it separately. Aziz (2020) reported 1 target vessel MI (0.5%). Rodriguez-Leor (2024) reported a 30-day MI incidence of 2.4%, all occurring in people with ACS. Aksoy (2019) reported no cases of MI in their study cohort.

Mortality rate

The mortality rate occurring within the follow-up period, whether related to the procedure or from other causes, was reported in several studies. Sagris (2024) reported an in-hospital mortality rate of 2% (95% CI 1% to 3%). Caminiti (2023) did not report specific mortality rates in their study. Wiens (2021) reported in-hospital mortality unrelated to IVL in 3 people. Cubero-Gallego (2022) reported a long-term mortality rate of 3.7% (cardiac death) at a median follow-up of 20 months. Aziz (2020) reported 2 cardiac deaths (1%). Rodriguez-Leor (2024) reported a 30-day mortality rate of 1.2%.

Periprocedural complications

Periprocedural complications, including perforations, dissections, slow flow and no-reflow phenomena, were reported during or immediately after the procedure across multiple studies. Sagris (2024) reported rare complications, including perforations (1%), dissections (2%), slow flow (0%) and no-reflow phenomena (0%). Wiens (2021) found no cases of distal embolisation, coronary perforation or dissection. Caminiti (2023) reported procedural complications with a pooled rate of 1.6% (95% CI 0.3% to 2.9%), including specific cases of dissection and perforation. Cubero-Gallego (2022) noted rare periprocedural complications, including dissections (2.8%) and no instances of slow flow or no-reflow. Aksoy (2019) reported no cases of perforation, slow flow or no-reflow phenomena, but observed 7 balloon ruptures during treatment without any adverse sequelae. In addition, Rodriguez-Leor (2024) reported a 0.7% incidence of coronary perforation and a 2.4% incidence of coronary dissection, all managed successfully.

Anecdotal and theoretical adverse events

Expert advice was sought from consultants who have been nominated or ratified by their professional society. They were asked if they knew of any other adverse events for this procedure that they had heard about (anecdotal), which were not reported in the literature. They were also asked if they thought there were other adverse events that might possibly occur, even if they had never happened (theoretical).

Six professional expert questionnaires for this procedure were submitted. Find full details of what the professional experts said about the procedure in the specialist advice questionnaires for this procedure.

Validity and generalisability

Sample size and follow-up

The studies collectively included a total of about 4,300 people, with follow-up periods varying from in-hospital to several months. The longest follow-up period reported was a median of 20 months in the prospective study by Cubero-Gallego (2022). Most studies, such as the multicentre systematic review and meta-analysis by Sagris (2024) and the retrospective cohort study by Wiens (2021), reported follow-up data up to 30 days. The systematic review and meta-analysis by Caminiti (2023) included a mean follow-up of 2.6 months.

Sources of bias

The retrospective nature of some studies, such as those by Wiens (2021) and Rola (2022), introduces potential bias because of the reliance on previously recorded data and the lack of randomisation. Also, the non-randomised design of studies like Caminiti (2023) and Aksoy (2019) can contribute to selection bias and limit the generalisability of the findings.

Variability in inclusion and exclusion criteria

There was significant variability in the inclusion and exclusion criteria across the studies. For example, some studies, such as Caminiti (2023) and Rodriguez-Leor (2024), included people with specific comorbidities such as diabetes mellitus and chronic kidney disease, whereas others, such as Wiens (2021), excluded patients with certain conditions or lesions. This variability can affect the generalisability of the results, as different patient populations may respond differently to IVL. The diverse inclusion and exclusion criteria across studies necessitate careful consideration when interpreting the overall efficacy and safety outcomes of IVL.

Other considerations

The diversity in study design, patient populations and settings provides a broad perspective on the use of IVL in treating calcified coronary lesions.

Ongoing trials

Registry of Coronary Lithotripsy in Spain. NCT04298307
Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus NCT05649488
Rotablation vs Intravascular Lithotripsy in Calcified Coronary Lesions NCT04960319
FORWARD PAD IDE Study With the Shockwave Mini S IVL Catheter (FORWARD PAD) NCT05858905
Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions (ROLLING-STONE) NCT05016726
Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy NCT04698902
POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling (POWER-PAD-1) NCT05192473
Use of Shockwave M5+ IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access (SHOCK-ACCESS) NCT05880641
Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions (BALI) NCT04253171
Disrupt CAD III Post-Approval Study (PAS) NCT05021757
Intravascular Balloon Lithotripsy in Left Main Stem Percutaneous Coronary Intervention NCT04319666
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR (ILIT) NCT05862558
ROtational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified STEnosis (ROLLERCOASTR) NCT04181268
Coronary Intravascular Lithotripsy System in Patients With Coronary Artery Calcification (VIGOUR) NCT05818098
A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Lithotripsy Catheter (PINNACLE-I) NCT05828173
Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions (CCS) NCT04428177
ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2 (ISAR-CALC2) NCT05072730
Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial (Short-Cut) NCT06089135
Atherectomy vs Intravascular Lithotripsy (RAINBOW) NCT04013906
CRUSTAL Study in China NCT05828186
Shockwave Induced Attenuation of Calcified Plaques Quantified NCT05973994
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease (EMPOWER CAD) NCT05755711
Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO) NCT05966662
Clinical Trial of T-wave™ Coronary Lithotripsy Catheter System NCT05552131
The GISE (Società Italiana di Cardiologia Interventistica) - ShockCalcium Registry NCT05455515
ShOckwave ballooN or Atherectomy With Rotablation in Calcified Coronary Artery Lesions, the SONAR Trial (SONAR) NCT05208749
The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial (VICTORY) NCT05346068
The Lower Silesia Shockwave Registry (LSSR) NCT05916898
BASIL Study: A randomised comparison study on the treatment of calcified (hard and concrete-like) coronary artery using the conventional balloon angioplasty prior stenting versus the use of Shockwave Intravascular Lithotripsy (S-IVL) prior to stenting. ACTRN12620000086965
EMPOWER CAD: Equity in modifying plaque of women with undertreated calcified coronary artery disease. NCT05755711
Shockwave IVL to aid DCB only PCI [Germany] NCT05625997

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Interventional procedure overview of intravascular lithotripsy to treat calcified coronary arteries during percutaneous coronary intervention