Coronary Artery Disease
Conditions
Keywords
drug coated balloon, Paclitaxel, sirolimus
Brief summary
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon
Detailed description
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon. Prospective, multicenter, randomized, single-blind, 70 patients. Experimental intervention: Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²). Control intervention: Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²). Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months. clinical follow up.
Interventions
DEVICEPCB PTCA
Predilatation of coronary de-novo stenosis followed by a PCB
DEVICESCB PTCA
Predilatation of coronary de-novo stenosis followed by a SCB
Sponsors
InnoRa GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| late lumen loss in-segment | 6 months | angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | 5 days | combined endpoint of: \< 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE |
| MACE | at 6 and at 12 months | combined endpoint of: cardiac death, target vessel myocardial infarction, and TLR target lesion revascularization in-hospital at 6 and at 12 months |
Countries
Malaysia
Outcome results
None listed