Using Shockwave IVL with Drug-Coated Balloons for Calcified Lesions in Small Coronary Vessels
Official title: Intravascular Lithotripsy Plus Drug-coated Balloon in Calcified Small Coronary Vessels: a Feasibility Exploratory Study
Run by Rede Optimus Hospitalar SA · NCT05625997 · Data updated 2026-11-12
This study is testing if using shockwave therapy with special drug-coated balloons can help people with hard-to-treat blockages in small coronary arteries feel better and improve their heart health.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Rede Optimus Hospitalar SA Research network |
| Locations | 2 sites (São Paulo and 1 other locations) |
| Status | Recruiting |
| Started | June 16, 2023 |
| Main results expected | June 30, 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | May 16, 2025 |
| Trial ID | NCT05625997 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with coronary artery disease requiring intervention for calcified lesions in small vessels.
✕Probably not a fit
Patients with previous interventions near the target segment, long lesions, or specific lesion types such as bifurcation or thrombus-containing lesions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the effectiveness of intravascular lithotripsy (IVL) combined with drug-coated balloons (DCB) for treating calcified lesions in small coronary arteries. The study aims to determine if IVL can improve the outcomes of balloon dilatation in these challenging cases, where traditional drug-eluting stents may pose higher risks. Patients eligible for this study must have significant coronary artery disease and meet specific criteria regarding lesion characteristics. The study will be conducted at multiple locations, including a prominent hospital in São Paulo and a university in Verona.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with calcified lesions in small coronary vessels.
How similar studies have gone: Previous studies have shown promising results with drug-coated balloons in similar contexts, suggesting potential success for this novel combination approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hospital Israelita Albert Einstein
São Paulo, Brazil Recruiting -
University of Verona
Verona, Italy Recruiting
Study contacts
- Principal investigator: Flavio Ribichini, MD — Universita di Verona
- Study coordinator: Annelena Held-Wehmöller, PhD
- Email: shockwave_dcb@redeoptimus.com
- Phone: +4915785128140
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.