Shockwave IVL + DCB

Recruiting now

Conditions studied: Calcified Lesions in Small Coronary Vessels

In brief

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.

Key facts

Study ID

NCT05625997

Run by

Rede Optimus Hospitalar SA

People needed

50

Starts

2023-06-16

Expected to finish

2026-06-30

Last updated by the study team

2025-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Verona — Verona, Italy (enrolling)
• Hospital Israelita Albert Einstein — São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.