Shockwave IVL + DCB

NCT05625997 | Recruiting

• 1 other identifier: RO-220203
• Study Type: observational
• Target: 50
• Locations: 2 countries
• Sites: 2

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.

Conditions

Calcified Lesions in Small Coronary Vessels

Outcome Measures

Primary Outcomes (1)

• Successful IVL plus DCB

  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.

  at 1 month follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a diminished blood flow in their calcified small coronary vessels

You may qualify if:

• Age 18 years or older
• 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.
• Written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Rede Optimus Hospitalar SA: lead

Study Sites (2)

Hospital Israelita Albert Einstein

São Paulo, Brazil

RECRUITING

University of Verona

Verona, Italy

RECRUITING

Study Officials

• Flavio Ribichini, MD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

• Pedro Lemos, MD

  Hospital Israelita Albert Einstein, São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annelena Held-Wehmöller, PhD

CONTACT

+4915785128140; shockwave_dcb@redeoptimus.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: June 16, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

IT (1); BR (1)