Actively Recruiting

Age: 18Years +
All Genders
NCT05625997

Shockwave IVL + DCB

Led by Rede Optimus Hospitalar SA · Updated on 2025-05-16

50

Participants Needed

2

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Shockwave IVL + DCB

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Coronary artery disease requiring percutaneous intervention for one or more lesions with diameter stenosis greater than 50% by visual analysis
  • Coronary vessel diameter less than 3.0 mm by visual analysis
  • Severe calcification at the target lesion shown by fluoroscopic radiopacities on both sides of the arterial wall or by IVUS/OCT showing a calcium angle of at least 270 degrees
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Previous coronary intervention at or within 10 mm of the target lesion at any time
  • Lesion length 40 mm or longer
  • Planned use of atherectomy or cutting/scoring balloon
  • Bifurcation lesion
  • Lesion containing thrombus
  • Life expectancy less than 12 months due to other serious medical conditions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hospital Israelita Albert Einstein

São Paulo, Brazil

Actively Recruiting

2

University of Verona

Verona, Italy

Actively Recruiting

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Research Team

A

Annelena Held-Wehmöller, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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