Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone
Recruiting
N/A
Interventional Study
Drug Coated Balloon
Bioresorbable Scaffold
Percutaneous Coronary Intervention (PCI)
Acute Coronary Syndrome (ACS)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 68
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 2,256 (estimated)
- Sponsor
- Ceric Sàrl · Industry
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About This Trial
The goal of this study is to investigate the equivalence in early and long-term efficacy between the two "Leave nothing behind strategies" (Drug-Coated Baloon \[DCB\] strategy with bail-out BioResorbable Scaffold \[BRS\] versus BRS strategy) of de-novo native coronary artery lesions in a relatively young Percutaneous Coronary Intervention (PCI) population, to be more specific, Patients with Chroni…
Trial Locations
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Eligibility 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 t…
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