Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
Study NCT ID:
NCT03908450
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2019-04-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter
Sponsor:
InnoRa GmbH
Organization:
Study Overview
Official Title:
Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCBDENOVO
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
Key inclusion criteria: \> 18 years of age, 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%).
Key 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.
Primary efficacy endpoint: late lumen loss in-segment at 6 months. Key secondary endpoints: Procedural Success: \< 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE. MACE: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization in-hospital at 6 and at 12 months Individual clinical endpoints at 6 and at 12 months: cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, (stenosis ≥ 50% at follow-up angiography)
Key inclusion criteria: \> 18 years of age, 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%).
Key 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.
Primary efficacy endpoint: late lumen loss in-segment at 6 months. Key secondary endpoints: Procedural Success: \< 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE. MACE: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization in-hospital at 6 and at 12 months Individual clinical endpoints at 6 and at 12 months: cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, (stenosis ≥ 50% at follow-up angiography)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: