Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon

Study 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.

Official Title
-----------------
Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon

Conditions
-----------------
DES In-stent Stenosis

Intervention / Treatment
-----------------
* Device: Paclitaxel coated balloon (SeQuent Please)
* Device: Sirolimus coated balloon


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sirolimus coated Balloon<br>treatment of coronary DES-ISR with a sirolimus coated balloon | Device: Sirolimus coated balloon<br>* Sirolimus coated balloon<br>|
| Active Comparator: Paclitaxel coated balloon (SeQuent Please)<br>treatment of coronary DES-ISR with a paclitaxel coated balloon | Device: Paclitaxel coated balloon (SeQuent Please)<br>* Paclitaxel coated balloon (SeQuent Please)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late lumen loss | Difference between minimal lumen diameter at follow-up coronary angiography and baseline after PCI | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | ≤ 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 | 24 hours | 
| MACE (Major adverse cardiac events) | 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. | 12 months |