Status:
COMPLETED
Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon
Lead Sponsor:
InnoRa GmbH
Conditions:
Coronary Restenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Treatment of coronary in-stent restenosis (ISR) by a sirolimus coated SEQUENT® SCB RAPID EXCHANGE PTCA balloon catheter or a paclitaxel coated SEQUENT® PLEASE PTCA balloon catheter
Detailed Description
Experimental intervention: Predilatation of coronary ISR with POBA followed by a sirolimus coated SeQuent®SCB balloon balloon (sirolimus 4.0 μg/mm²) Control intervention: Predilatation of coronary IS...
Eligibility Criteria
Inclusion
- 18 years of age
- Clinical evidence of stable or unstable angina (acute coronary syndrome) or a positive functional study
- Patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis by visual estimation or ≥50% and positive functional study) including margin-stenosis with max 5 mm distance to the stent
Exclusion
- 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, reference vessel diameter \< 2.5 mm
Key Trial Info
Start Date :
July 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03242096
Start Date
July 21 2017
End Date
January 31 2021
Last Update
August 27 2021
Active Locations (5)
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1
Clinical and Experimental Interventional Cardiology
Homburg, Saarland, Germany, 66421
2
Klinik für Innere Medizin und Kardiologie
Dresden, Germany, 01307
3
Deutsches Zentrum für Herz und Kreislauf
Mainz, Germany, 55131
4
Dept. of Internal Medicine II
Ulm, Germany