Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- DES In-stent Stenosis
- Sponsor
- InnoRa GmbH
- Enrollment
- 50
- Locations
- 5
- Primary Endpoint
- Late lumen loss
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.
Detailed Description
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis. Patient population will consist of male and female adults suffering from coronary drug-eluting stent (DES) restenosis, which is to be treated by a study balloon according to the inclusion and exclusion criteria as defined below. In Late lumen loss lesion (difference between the angiographic in-lesion MLD post procedural and at 6 months follow-up) will be evaluated by quantitative coronary angiography (QCA). The study will be performed as a single-blind, SQP controlled study in 4 - 6 study centers in 50 patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years of age
- •Clinical evidence of stable or unstable angina (acute coronary syndrome) or a positive functional study
- •Patients with ≤ 2 primary drug-eluting stent in-stent restenosis (DES-ISR) lesions (≥ 70% diameter stenosis by visual estimation or ≥ 50% and positive functional study) including margin stenosis with max 5mm distance to the stent.
Exclusion Criteria
- •Chronic renal insufficiency with serum creatinine levels \> 2.0 mg per deciliter
- •Known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or sirolimus, and sensitivity to contrast media not amenable to premedication
- •Concomitant medical illness associated with a life-expectancy of less than two year
- •Lesion length (ISR) \> 35 mm, vessel diameter \< 2.5 mm
Outcomes
Primary Outcomes
Late lumen loss
Time Frame: 6 months
Difference between minimal lumen diameter at follow-up coronary angiography and baseline after PCI
Secondary Outcomes
- Procedural Success(24 hours)
- MACE (Major adverse cardiac events)(12 months)