Condition: Coronary Artery Disease (CAD) · Sponsor: B. Braun Melsungen AG
The main objective of this randomized, multicenter, international, open-label clinical trial is to demonstrate that, in the context of percutaneous coronary intervention for complex coronary artery disease, a SeQuent® SCB interventional strategy is non-inferior to a new-generation DES strategy in terms of a 12- and 36-month composite of Target Vessel Failure (TVF), that includes: * cardiovascular death (CV death), * target vessel related MI (TV-MI), * clinically indicated target vessel revascularization (ci-TVR), * bleeding according to Bleeding Academic Research Consortium (BARC) Types 3-5. Eligible subjects will be assigned in a 1:1 ratio to receive treatment of all lesions with either the SeQuent® SCB-based strategy or a DES-based strategy. The randomization will be performed prior to the index procedure once signed informed consent has been obtained and all eligibility criteria have been confirmed. All Subjects will be followed for clinical outcomes at 3 months, 1, 2, and 3 years. A subset of 138 randomized patients will undergo control angiography after one-year clinical follow-up (+1 month). An independent core laboratory will analyze all baseline angiograms. If, at 36 months, the non-inferiority of the SeQuent® SCB strategy compared to the DES strategy is achieved, superiority in terms of TVF and BARC Type 3-5 bleeding will be tested. An optional extension of follow-up to 6 years may be implemented based on interim results and the joint decision of the Steering C…
This description comes directly from the study's public registry record.
Jiani Wang, Dr. · +49 151 46206456 · Jiani.Wang@bbraun.com
Franziska Greifzu, Dr. · +49 30 568207371 · Franziska.Greifzu@bbraun.com
Always discuss trial participation with your own doctor first.
| Universität des Saarlandes - Klinik für Innere Medizin III | Homburg, Germany | Not Yet Recruiting |
| University Hospital Basel | Basel, Switzerland | Not Yet Recruiting |
| Stadtspital Zürich - Klinik für Kardiologie | Zurich, Switzerland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07363161