Clinical trial NCT03242096: Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Restenosis
Lead sponsor: InnoRa GmbH
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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 ISR with POBA followed by a paclitaxel coated SeQuent® Please balloon or SeQuent® Please NEO balloon (paclitaxel 3.0 μg/mm²)
Primary purpose: TREATMENT

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 ISR with POBA followed by a paclitaxel coated SeQuent®Please balloon or SeQuent®Please NEO balloon (paclitaxel 3.0 μg/mm²)

Duration of intervention per patient: minutes

Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months clinical follow up

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 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 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, reference vessel diameter \< 2.5 mm

Primary outcomes:
measure: late lumen loss in-lesion at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Procedural Success
timeFrame: during hospital stay of index procedure
measure: MACE
timeFrame: 6 and 12 months
measure: Individual clinical endpoints
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Clinical and Experimental Interventional Cardiology
state: Saarland
city: Dresden
country: Germany
facility: Klinik für Innere Medizin und Kardiologie
city: Mainz
country: Germany
facility: Deutsches Zentrum für Herz und Kreislauf
city: Ulm
country: Germany
facility: Dept. of Internal Medicine II
city: Basel
country: Switzerland
facility: Universitätsspital Basel
Study officials:
affiliation: University of Saarland
name: Bruno Scheller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.
citation: Scheller B, Mangner N, Abdul Kader MASK, Wan Ahmad WA, Jeger R, Wohrle J, Ong TK, Liew HB, Gori T, Mahfoud F, Nuruddin AA, Woitek F, Abidin IZ, Schwenke C, Schnorr B, Mohd Ali R. Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions. Circ Cardiovasc Interv. 2022 Sep;15(9):e012305. doi: 10.1161/CIRCINTERVENTIONS.122.012305. Epub 2022 Sep 20.