FIMLIMUSDCB: Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sirolimus coated Balloon treatment of coronary DES-ISR with a sirolimus coated balloon |
Device: Sirolimus coated balloon
Sirolimus coated balloon
|
| Active Comparator: Paclitaxel coated balloon (SeQuent Please) treatment of coronary DES-ISR with a paclitaxel coated balloon |
Device: Paclitaxel coated balloon (SeQuent Please)
Paclitaxel coated balloon (SeQuent Please)
|
Outcome Measures
Primary Outcome Measures
- Late lumen loss [6 months]
Difference between minimal lumen diameter at follow-up coronary angiography and baseline after PCI
Secondary Outcome Measures
- Procedural Success [24 hours]
≤ 30% final stenosis, TIMI III flow, no flow-limiting dissection at the conclusion of the procedure, and the absence of in-hospital (24 hour after treatment) MACE
- MACE (Major adverse cardiac events) [12 months]
MACE will be defined as the occurrence of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 6 months and 12 months.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Queen Elizabeth Hospital II | Kota Kinabalu | Malaysia | 88300 | |
| 2 | National Heart Institute | Kuala Lumpur | Malaysia | 50400 | |
| 3 | University Malaya | Kuala Lumpur | Malaysia | 50603 | |
| 4 | Sarawak Genaral Hospital Heart Centre | Kuching | Malaysia | 94300 | |
| 5 | Hospital Pulau Pinang | Pulau Pinang | Malaysia | 10990 |
Sponsors and Collaborators
- InnoRa GmbH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SI01