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

August 24, 2021 updated by: InnoRa GmbH

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Klinik fur Innere Medizin und Kardiologie
      • Mainz, Germany, 55131
        • Deutsches Zentrum für Herz und Kreislauf
      • Ulm, Germany
        • Dept. of Internal Medicine II
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Clinical and Experimental Interventional Cardiology
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitätsspital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sirolimus coated balloon
Treatment of in-stent restenosis with a sirolimus coated balloon
Combination product: Sirolimus coated balloon
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)
ACTIVE_COMPARATOR: Paclitaxel coated balloon
Treatment of in-stent restenosis with a paclitaxel coated balloon
Combination product: Paclitaxel coated balloon
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
late lumen loss in-lesion at 6 months
Time Frame: 6 months
late lumen loss in-lesion at 6 months assessed by blinded QCA
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during hospital stay of index procedure
MACE
Time Frame: 6 and 12 months
cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization
6 and 12 months
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)
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InnoRa GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 21, 2017

Primary Completion (ACTUAL)

August 1, 2020

Study Completion (ACTUAL)

January 31, 2021

Study Registration Dates

First Submitted

July 31, 2017

First Submitted That Met QC Criteria

August 5, 2017

First Posted (ACTUAL)

August 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI-ISR-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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