Shockwave IVL + DCB

Last updated: May 13, 2025
Sponsor: Rede Optimus Hospitalar SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05625997
RO-220203
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 years or older

  2. Coronary artery disease with percutaneous intervention clinically indicated to treatone 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 fluoroscopicradiopacities noted without cardiac motion prior to contrast injectioninvolving both sides of the arterial wall in at least 1 location ORIntravascular Ultrasound/Optical Coherence Tomography (IVUS/OCT) demonstratedcalcium angle of ≥270° on at least 1 cross section.

  1. Written informed consent

Exclusion

Exclusion Criteria:

  1. Previous coronary intervention at or < 10 mm distant from target segment at anytime.

  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 limitpatient's ability to participate in clinical study

Study Design

Total Participants: 50
Study Start date:
June 16, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Hospital Israelita Albert Einstein

    São Paulo,
    Brazil

    Active - Recruiting

  • University of Verona

    Verona,
    Italy

    Active - Recruiting

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