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NCT Number: NCT05625997

Shockwave IVL + DCB

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.

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Key information

Conditions

Calcified Lesions in Small Coronary Vessels

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Israelita Albert Einstein, São Paulo, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Successful IVL plus DCB

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annelena Held-Wehmöller, PhD

CONTACT

[email protected]

+4915785128140

Sponsors and collaborators

Lead sponsor

Rede Optimus Hospitalar SA

Network

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 23, 2022
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.