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Clinical trial Recruiting at 1 site Interventional Ages 18 to 68

Drug-coated balloon with bail-out bioresorbable scaffold versus scaffold alone for new coronary artery blockages

Official title: 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.

Run by Ceric Sàrl · NCT07038408 · Data updated 2026-11-12

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.

More Percutaneous Coronary Intervention (PCI) trials

Quick facts

Study typeInterventional
Ages18 Years to 68 Years
SexAll
Enrollment2256 (estimated)
SponsorCeric Sàrl
Industry-sponsored
Locations1 site (Tallinn)
StatusRecruiting
StartedApril 24, 2026
Main results expectedNovember 30, 2028
Study endsMarch 2032
Registry record updatedApril 30, 2026
Trial IDNCT07038408 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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).

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Põhja-Eesti Regionaalhaigla
    Tallinn, Estonia     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.