DES In-stent Stenosis
Conditions
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.
Interventions
DEVICEPaclitaxel coated balloon (SeQuent Please)
Paclitaxel coated balloon (SeQuent Please)
DEVICESirolimus coated balloon
Sirolimus coated balloon
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late lumen loss | 6 months | Difference between minimal lumen diameter at follow-up coronary angiography and baseline after PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Malaysia
Outcome results
None listed