Shockwave IVL + DCB

NCT ID: NCT05625997

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-16
• Study Completion Date: 2026-06-30

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rede Optimus Hospitalar SA

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flavio Ribichini, MD

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Pedro Lemos, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein, São Paulo

Locations

Hospital Israelita Albert Einstein

São Paulo, , Brazil

Site Status: RECRUITING

University of Verona

Verona, , Italy

Site Status: RECRUITING

Countries

Brazil; Italy

Central Contacts

Annelena Held-Wehmöller, PhD

Role: CONTACT

shockwave_dcb@redeoptimus.com

+4915785128140

Facility Contacts

Pedro Lemos, MD

Role: primary

Flavio Ribichini, MD

Role: primary

Other Identifiers

RO-220203

Identifier Type: -

Identifier Source: org_study_id