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

Primary Purpose

Coronary Restenosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sirolimus coated balloon
Paclitaxel coated balloon
Sponsored by
InnoRa GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Restenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical and Experimental Interventional Cardiology
  • Klinik für Innere Medizin und Kardiologie
  • Deutsches Zentrum für Herz und Kreislauf
  • Dept. of Internal Medicine II
  • Universitätsspital Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sirolimus coated balloon

Paclitaxel coated balloon

Arm Description

Treatment of in-stent restenosis with a sirolimus coated balloon

Treatment of in-stent restenosis with a paclitaxel coated balloon

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Procedural Success
< 30% final stenosis, TIMI III flow, no flow-limiting dissection, and the absence of in-hospital MACE
MACE
cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization
Individual clinical endpoints
stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, binary restenosis (stenosis ≥ 50% at follow-up angiography)

Full Information

First Posted
July 31, 2017
Last Updated
August 24, 2021
Sponsor
InnoRa GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03242096
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 21, 2017 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InnoRa GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Restenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
Outcomes Assessor
Masking Description
Blinded QCA for primary outcome
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sirolimus coated balloon
Arm Type
Experimental
Arm Description
Treatment of in-stent restenosis with a sirolimus coated balloon
Arm Title
Paclitaxel coated balloon
Arm Type
Active Comparator
Arm Description
Treatment of in-stent restenosis with a paclitaxel coated balloon
Intervention Type
Combination Product
Intervention Name(s)
Sirolimus coated balloon
Intervention Description
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)
Intervention Type
Combination Product
Intervention Name(s)
Paclitaxel coated balloon
Intervention Description
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 Outcome Measure Information:
Title
late lumen loss in-lesion at 6 months
Description
late lumen loss in-lesion at 6 months assessed by blinded QCA
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Procedural Success
Description
< 30% final stenosis, TIMI III flow, no flow-limiting dissection, and the absence of in-hospital MACE
Time Frame
during hospital stay of index procedure
Title
MACE
Description
cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization
Time Frame
6 and 12 months
Title
Individual clinical endpoints
Description
stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, binary restenosis (stenosis ≥ 50% at follow-up angiography)
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Scheller, MD
Organizational Affiliation
University of Saarland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Experimental Interventional Cardiology
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Klinik für Innere Medizin und Kardiologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Deutsches Zentrum für Herz und Kreislauf
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Dept. of Internal Medicine II
City
Ulm
Country
Germany
Facility Name
Universitätsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17101615
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.
Results Reference
result
PubMed Identifier
36126132
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.
Results Reference
derived

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

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