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CompletedNCT03242096Updated Aug 27, 2021

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

An interventional study of Sirolimus coated balloon and Paclitaxel coated balloon in Coronary Restenosis, sponsored by InnoRa GmbH. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-27.

Sponsored by InnoRa GmbH · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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

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Conditions studied

  • Coronary Restenosis

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03

In context

Coronary Restenosis

97 studies on the registry are indexed under Coronary Restenosis; 9 are open to participants now.

This study's enrollment of 50 is below the median of 240 across 59 interventional studies indexed under Coronary Restenosis.

Browse Coronary Restenosis studies →

Lead sponsor

InnoRa GmbH is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Sirolimus coated balloon

    Treatment of in-stent restenosis with a sirolimus coated balloon

    Combination Product: Sirolimus coated balloon

  • Active comparator
    Paclitaxel coated balloon

    Treatment of in-stent restenosis with a paclitaxel coated balloon

    Combination Product: Paclitaxel coated balloon

Interventions

  • Combination productSirolimus 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)

  • Combination productPaclitaxel 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)

06

What researchers measure

Primary outcomes

  1. late lumen loss in-lesion at 6 months

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

    Time frame: 6 months

Secondary outcomes

  1. Procedural Success

    \< 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

  2. MACE

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

    Time frame: 6 and 12 months

  3. Individual clinical endpoints

    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

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Study locations

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

Publications

  • 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. PubMed 17101615 ↗
  • 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. PubMed 36126132 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03242096
Lead sponsor
InnoRa GmbH
Responsible party
Sponsor
First posted
Aug 8, 2017
Start date
Jul 21, 2017
Primary completion
Aug 1, 2020
Completion
Jan 31, 2021
Last update
Aug 27, 2021

Study contacts

Bruno Scheller, MD
principal investigator · University of Saarland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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