Coronary Artery Disease Clinical Trial
— SCBDENOVOOfficial title:
Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter
Verified date | February 2024 |
Source | InnoRa GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon
Status | Completed |
Enrollment | 70 |
Est. completion date | July 31, 2023 |
Est. primary completion date | April 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Clinical evidence of stable or unstable angina or a positive functional study - Patients with significant coronary de-novo stenosis (= 70% diameter stenosis or intermediate = 50% to <70% diameter stenosis with positive functional test or symptom of ischemia) - Successful lesion preparation (no flow-limiting dissection or a residual stenosis > 30%) Exclusion Criteria: - Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI) - Intolerance and / or allergy to Sirolimus - Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: iopromide) - Patients with an ejection fraction of < 30 % - Reference vessel diameter (RVD) < 2.5 mm - Contraindication for whichever necessary accompanying medication |
Country | Name | City | State |
---|---|---|---|
Germany | Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden | Dresden | |
Germany | Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes | Homburg/Saar | Saarland |
Germany | Klinik für Innere Medizin III - Kardiologie Paul Gerhardt Stift | Wittenberg | |
Switzerland | Universitätsspital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
InnoRa GmbH |
Germany, Switzerland,
Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | late lumen loss in-segment | angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline | 6 months | |
Secondary | Procedural Success | < 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE | in hospital | |
Secondary | MACE MACE | cardiac death, target vessel myocardial infarction, and TLR target lesion revascularization in-hospital at 6 and at 12 months | at 6 and at 12 months |
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