Shockwave IVL + DCB

Intravascular Lithotripsy Plus Drug-coated Balloon in Calcified Small Coronary Vessels: a Feasibility Exploratory Study

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.

Study Overview

• Status: Recruiting
• Conditions: Calcified Lesions in Small Coronary Vessels

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Annelena Held-Wehmöller, PhD; Phone Number: +4915785128140; Email: shockwave_dcb@redeoptimus.com

Study Locations

• Brazil
  • São Paulo, Brazil
    • Recruiting
    • Hospital Israelita Albert Einstein
    • Contact: Pedro Lemos, MD
• Italy
  • Verona, Italy
    • Recruiting
    • University of Verona
    • Contact: Flavio Ribichini, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rede Optimus Hospitalar SA
• Investigators: Principal Investigator: Flavio Ribichini, MD, Universita di Verona; Principal Investigator: Pedro Lemos, MD, Hospital Israelita Albert Einstein, São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RO-220203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No