A Prospective, Randomized, Controlled, Open Label, Multicenter Trial to Test the Non-inferiority of Drug Eluting Balloon vs. Drug Eluting Stent Treatment in de Novo Stenoses of Small Native Vessels Regarding Efficacy and Safety
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 758
- Locations
- 24
- Primary Endpoint
- Major adverse cardiac events
Study Overview
Brief Summary
The investigators hypothesize that in a real-world population undergoing percutaneous coronary intervention (PCI) for de-novo stenoses in small native vessels with a diameter <3 mm, drug eluting balloons (DEB) are non inferior to third-generation drug eluting stents (DES).
Detailed Description
Drug-eluting balloons are an established treatment for in-stent stenoses and showed good results in small vessels. Moreover, the available data suggest that DEB are a promising new technique for the treatment of de-novo stenoses in small vessels if pre-dilatation is performed and geographical mismatch is avoided.
The aim of this study is to demonstrate that DEB is non-inferior to DES in a real-world population with respect to the combined clinical endpoint Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Angina pectoris Canadian Cardiovascular Society (CCS) 2 to 4 or silent ischemia as assessed by stress echocardiography, stress cardiac magnetic resonance, myocardial perfusion scintigraphy, or fractional flow reserve
- •PCI of de-novo stenosis in vessels ≥2.0 to <3.0 mm in diameter irrespective of the indication (concomitant PCI of a vessel ≥3.0 mm in diameter is permitted if the stenosis is located in a coronary artery other than the culprit vessel)
- •No flow-limiting dissection (TIMI ≤2) or residual stenosis >30% after initial dilatation with a standard or non-compliant balloon, as assessed by the physician in charge
- •Written informed consent
Exclusion Criteria
- •Concomitant large-diameter PCI in the same coronary artery (LAD, Ramus circumflexus (RCX), RCA)
- •PCI of instent-restenosis (culprit lesion)
- •Life expectancy <12 months
- •Pregnancy
- •Enrolled in another coronary intervention study
- •Unable to give informed consent
Outcomes
Primary Outcomes
Major adverse cardiac events
Time Frame: 12 month
Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.
Secondary Outcomes
- Cost-effectiveness(12/24/36 month)
- Quantitative Coronary Analysis (QCA)(12 months)
- Outcome in patients with high bleeding risk including patients on OAC(12 months)
- Outcome in acute versus stable CAD(12 months)
- Outcome in diabetics vs non diabetics(12 months)
- sex specific inequalities in the use of drug coated balloons for small coronary artery disease(12 months)
- MACE(24/36 month)
- Revascularization(12/24/36 month)
- Stent Thrombosis(12/24/36 month)
- Thrombolysis In Myocardial Infarction(12/24/36 month)