Drug-coated balloon with bail-out bioresorbable scaffold versus scaffold alone for new coronary artery blockages
Multi-center, Open-label, Prospective, Randomized Study to Show Long-term Efficacy of DCB Treatment With Bail-out BRS in Comparison to BRS Treatment of De-novo Native Coronary Artery Lesions in a Relatively Young PCI Population.
NA · Ceric Sàrl · NCT07038408
This test sees if using a drug-coated balloon with bail-out bioresorbable scaffold works as well as using a bioresorbable scaffold alone for adults 18–68 getting PCI for new coronary artery blockages, including certain heart attacks and unstable angina.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2256 (estimated) |
| Ages | 18 Years to 68 Years |
| Sex | All |
| Sponsor | Ceric Sàrl (industry) |
| Locations | 1 site (Tallinn) |
| Trial ID | NCT07038408 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, open-label, multicenter comparison of two "leave nothing behind" PCI strategies: a drug-coated balloon (DCB) approach with bail-out bioresorbable scaffold (BRS) versus a BRS-alone strategy. The primary clinical endpoint is target-vessel failure (cardiovascular death, target-vessel MI, or ischemia-driven target-vessel revascularization) at 12 months, with a co-primary angiographic endpoint of in-segment net gain at 13 months in a substudy. Investigators plan to enroll about 2,256 patients in the main study and 196 in the angiographic substudy, with clinical follow-up extending to 60 months to capture longer-term outcomes. Eligible lesions are de novo native coronary lesions of low-to-moderate complexity in vessels 2.75–4.0 mm and lesion lengths up to 30 mm, with up to three target lesions per patient.
Who should consider this trial
Good fit: Adults 18–68 years old with de novo native coronary artery lesions (single or multivessel, low-to-moderate complexity) suitable for PCI, vessel diameter 2.75–4.0 mm, lesion length ≤30 mm and up to three target lesions, including patients with chronic coronary syndromes or selected non‑ST‑elevation ACS (NSTEMI or unstable angina).
Not a fit: Patients with recent STEMI (within 48 hours), severely calcified lesions, bifurcation lesions requiring a two‑device strategy, significant left main disease (≥50%), severe renal impairment (GFR <45 ml/min), limited life expectancy, pregnancy, allergy to required antiplatelet drugs, or other protocol exclusions are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the approach could let many patients avoid extensive permanent scaffold implantation while providing similar short- and long-term clinical results, potentially lowering late device-related complications.
How similar studies have performed: Drug-coated balloons have shown favorable results in some lesion types and in-stent restenosis, while fully bioresorbable scaffold strategies have had mixed results historically, so this combined "leave nothing behind" approach is partly supported by prior work but not yet definitively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≥ 18 years ≤ 68 years * Single vessel or multivessel disease with low to moderate complex de-novo native coronary artery lesions up to 30 mm length and reference vessel diameter 2.75-4.0 mm * Maximum of 3 target lesions * Maximal cumulative lesion length of all treated lesions 80 mm * Signed informed consent for participation in the study Exclusion Criteria: * ST-segment Elevation Myocardial Infarction (STEMI) treatment at index or in the previous 48 hours * Severe calcified lesions * Bifurcations lesions with planned 2 device strategy * Left-Main (LM) disease ≥ 50% diameter stenosis * More than 3 target lesions * Renal insufficiency with Glomerular Filtration Rate (GFR) \< 45 ml/min * Life expectancy less than 1 year * Known hypersensitivity or allergy to aspirin or P2Y12 receptor inhibitors * Incapable of providing written informed consent * Pregnant or breastfeeding women * Under judicial protection, tutorship, or curatorship * Participation in another trial
Where this trial is running
Tallinn
- Põhja-Eesti Regionaalhaigla — Tallinn, Estonia (RECRUITING)
Study contacts
- Study coordinator: DAVIDE CAPODANNO, Professor
- Email: dcapodanno@unict.it
- Phone: +39-3393238566
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Drug Coated Balloon, Bioresorbable Scaffold, Percutaneous Coronary Intervention, Acute Coronary Syndrome, MULTI-CENTER, OPEN-LABEL, PROSPECTIVE, RANDOMIZED STUDY