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Compares treatment options for Drug Coated Balloon
Official title Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone
ClinicalTrials.gov ID: NCT07038408
What this study is testing
- What it's testing
- 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 Chronic Coronary Syndromes (CCS) and Acute Coronary Syndrome (ACS) (Non-ST-segment Elevation Myocardial Infarction [NSTEMI] and Unstable angina) between 18-68 years of age scheduled for PCI. The main questions aim to answer are: DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 12 months compared to BRS strategy?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 68
You may be able to join if
- 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...
- Maximum of 3 target lesions
- Maximal cumulative lesion length of all treated lesions 80 mm
- Signed informed consent for participation in the study
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tallinn, Estonia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 68 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tallinn, Estonia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.