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Completed

NCT Number: NCT03242096

Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon

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

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Key information

Conditions

Coronary Restenosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical and Experimental Interventional Cardiology, Homburg, Saarland, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sirolimus coated balloon

Combination Product

Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a sirolimus coated balloon (SeQuent®SCB balloon with sirolimus 4.0 μg/mm²)

Paclitaxel coated balloon

Combination Product

Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a paclitaxel coated balloon (SeQuent®Please balloon or SeQuent®Please NEO balloon with paclitaxel 3.0 μg/mm²) (paclitaxel 3.0 μg/mm²)

Primary outcomes

  1. late lumen loss in-lesion at 6 months

    Time frame: 6 months

    late lumen loss in-lesion at 6 months assessed by blinded QCA

Secondary outcomes

  1. Procedural Success

    Time frame: during hospital stay of index procedure

    < 30% final stenosis, TIMI III flow, no flow-limiting dissection, and the absence of in-hospital MACE

  2. MACE

    Time frame: 6 and 12 months

    cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization

  3. Individual clinical endpoints

    Time frame: 6 and 12 months

    stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, binary restenosis (stenosis ≥ 50% at follow-up angiography)

Sponsors and collaborators

Lead sponsor

InnoRa GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Aug 8, 2017
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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