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NCT03242096
Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon
NA trial testing Sirolimus coated balloon in Coronary Restenosis in 50 participants. Completed in 31 January 2021.
1 August 2020
Quick facts
| Lead sponsor | InnoRa GmbH |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 21 July 2017 |
| Primary completion | 1 August 2020 |
| Estimated completion | 31 January 2021 |
| Sites | 5 locations across Switzerland, Germany |
Drugs / interventions tested
- Sirolimus coated balloon
- Paclitaxel coated balloon
Conditions studied
- Coronary Restenosis — all drugs for Coronary Restenosis →
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):
-
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 -
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:
- PubMed search for NCT03242096
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sirolimus coated balloon
Trials testing the same drug.
- NCT02996318 — Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon · NA · completed
Other recruiting trials for Coronary Restenosis
Currently open trials in the same condition.
- NCT06075602 — COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLE · recruiting
- NCT04988685 — SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With · recruiting
Other InnoRa GmbH trials
Trials by the same sponsor.
- NCT05445258 — Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon · NA · terminated
- NCT03908450 — Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter · NA · completed
- NCT04017364 — Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia · NA · completed
- NCT03332264 — Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions · NA · completed
- NCT02996318 — Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03242096 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by InnoRa GmbH
- Last refreshed: 27 August 2021
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing