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Compares treatment options for Coronary Artery Disease
Official title Drug-Coated Balloon Versus Drug-eluting Stent Angioplasty for Treatment of Chronic Total Occlusion - The DCB-CTO Trial
ClinicalTrials.gov ID: NCT07369765
What this study is testing
- What it's testing
- Chronic total occlusion (CTO) remains one of the most challenging lesions in coronary artery disease management. Percutaneous coronary intervention using drug-eluting stents is currently a standard treatment approach; however, drug-coated balloon angioplasty has emerged as a potential alternative strategy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Definite or probable CTO as per CTO-ARC definition
- CTO length ≥ 20 mm and ≤ 40 mm;
- High likelihood (≥90 %) of CTO-PCI success (balance between CTO lesion complexity and operator expertise);
- Successful treatment of any non-CTO lesions at least 1 month before randomization;
- CTO lesion location in a vessel segment with diameter ≥ 2.5 mm;
You likely can't join if
- Life expectancy \< 1 year as result of non-cardiac conditions;
- Multiple CTO lesions that require recanalization;
- Target lesion is an in-stent CTO;
- Angiographic grade 3 calcifications in the CTO segment (Appendix 2);
- Recent acute coronary syndrome (\< 1 month);
- Cardiogenic shock or inability to stay in supine position for long time;
See the full eligibility criteria
- Definite or probable CTO as per CTO-ARC definition
- CTO length ≥ 20 mm and ≤ 40 mm;
- High likelihood (≥90 %) of CTO-PCI success (balance between CTO lesion complexity and operator expertise);
- Successful treatment of any non-CTO lesions at least 1 month before randomization;
- CTO lesion location in a vessel segment with diameter ≥ 2.5 mm;
- Successful intraplaque (intraluminal) wiring (extraplaque tracking \< 10 mm or \< 50% of occlusion length) with no flow-limiting dissection and a TIMI flow ≥ 2 after initial predilation with NC balloon.
- Life expectancy \< 1 year as result of non-cardiac conditions;
- Multiple CTO lesions that require recanalization;
- Target lesion is an in-stent CTO;
- Angiographic grade 3 calcifications in the CTO segment (Appendix 2);
- Recent acute coronary syndrome (\< 1 month);
- Cardiogenic shock or inability to stay in supine position for long time;
- Severe kidney failure (eGFR ≤ 30 mL/min);
- Any planned non-CTO PCI \< 12 months after randomization;
- Anticipated less compliance of the patients to complete the following or taking medical therapy;
- Patient or legal representative unable or unwilling to provide written informed consent prior to study enrollment;
- Pregnancy or childbearing age unless a recent pregnancy test is negative.
The study team makes the final eligibility decision.
Where it's taking place
- Istanbul, Turkey (Türkiye)
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, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Istanbul, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
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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.