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NCT03242096

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

Completed NA Last updated 27 August 2021
What this trial tests

NA trial testing Sirolimus coated balloon in Coronary Restenosis in 50 participants. Completed in 31 January 2021.

Timeline
21 July 2017
Primary endpoint
1 August 2020
31 January 2021

Quick facts

Lead sponsorInnoRa GmbH
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment50
Start date21 July 2017
Primary completion1 August 2020
Estimated completion31 January 2021
Sites5 locations across Switzerland, Germany

Drugs / interventions tested

Conditions studied

Sponsor

InnoRa GmbH

Who can join

18 and older, any sex, with Coronary Restenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions.
    Scheller B, Mangner N, Abdul Kader MASK, Wan Ahmad WA, et al · · 2022 · cited 44× · PMID 36126132 · DOI 10.1161/circinterventions.122.012305
  2. Intrastent Restenosis: A Comprehensive Review.
    Bajeu IT, Niculescu AG, Scafa-Udriște A, Andronescu E. · · 2024 · cited 18× · PMID 38338993 · DOI 10.3390/ijms25031715

Verify or expand the search:

Other trials of Sirolimus coated balloon

Trials testing the same drug.

Other recruiting trials for Coronary Restenosis

Currently open trials in the same condition.

Other InnoRa GmbH trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03242096.

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