Shockwave IVL + DCB

Recruiting

• Conditions: Calcified Lesions in Small Coronary Vessels

• Registration Number: NCT05625997
• Lead Sponsor: Rede Optimus Hospitalar SA

Brief Summary

Drug-eluting stent (DES) implantation as interventional strategy for lesions in small coronary arteries is the current standard of care in many centers worldwide, but is associated with increased risk of late treatment failure in small vessels, as compared with larger coronary arteries. Randomized and observational studies have been shown that coronary intervention with drug-coated balloons (DCB) provide a promising alternative to DES implantation in small vessels, while avoiding the risk of a permanent vascular implant. Furthermore, lesions in small vessels are frequently concomitant with diffuse disease and/or distal location, where the presence of calcification is an additional common feature. Intravascular lithotripsy (IVL) has been recently introduced as a novel adjunctive technology to treat calcified lesions.

This study will explore the hypothesis that IVL has the potential to enhance the results of coronary balloon dilatation of small vessels with calcified lesions, therefore increasing the likelihood of optimal DBC intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-23
• Study Start: 2023-06-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age 18 years or older

2. Coronary artery disease with percutaneous intervention clinically indicated to treat one or more lesions fulfilling all criteria below:

   • De novo lesion with diameter stenosis > 50% (visual analysis)
   • Coronary vessel diameter < 3.0 mm (visual analysis)
   • Severe calcification at the target segment, defined as fluoroscopic radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least 1 location OR Intravascular Ultrasound/Optical Coherence Tomography (IVUS/OCT) demonstrated calcium angle of ≥270° on at least 1 cross section.

3. Written informed consent

Exclusion Criteria

1. Previous coronary intervention at or < 10 mm distant from target segment at any time.
2. Lesion length ≥ 40 mm.
3. Planned atherectomy or cutting/scoring balloon use.
4. Bifurcation lesion.
5. Thrombus containing lesion.
6. Life expectancy < 12 months due to other co-morbid condition(s) that could limit patient's ability to participate in clinical study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful IVL plus DCB	at 1 month follow-up	Successful IVL plus DCB in the absence of target lesion failure (TLF); "Successful IVL plus DCB" will be defined as a composite of: * IVL application at the target site, AND; * DCB inflation at the target site, AND; * Residual in-segment diameter stenosis \<40% by quantitative coronary angiography, in the absence of final serious angiographic complications (≥ Grade D dissection, perforation, abrupt closure, final TIMI flow ≤ II), AND; * Without the need for bailout scoring/cutting balloon or atherectomy-based strategy, AND; * Without the need for bailout stenting.; TLF will be defined as a composite of clinically driven revascularization, OR myocardial infarction, OR cardiac death related to the target lesion.

Trial Locations

Locations (2)

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, Brazil

University of Verona; 🇮🇹 Verona, Italy