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NCT02996318: FIMLIMUSDCB
Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon
NA trial testing Paclitaxel coated balloon (SeQuent Please) in DES In-stent Stenosis in 50 participants. Completed in 1 December 2017.
1 August 2017
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 | 1 December 2015 |
| Primary completion | 1 August 2017 |
| Estimated completion | 1 December 2017 |
| Sites | 5 locations across Malaysia |
Drugs / interventions tested
- Paclitaxel coated balloon (SeQuent Please)
- Sirolimus coated balloon
Conditions studied
- DES In-stent Stenosis — all drugs for DES In-stent Stenosis →
Sponsor
InnoRa GmbH
Who can join
18 and older, any sex, with DES In-stent Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon.
Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, et al · · 2019 · cited 115× · PMID 30898253 · DOI 10.1016/j.jcin.2018.11.040 -
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 -
The immune system in cardiovascular diseases: from basic mechanisms to therapeutic implications.
Wang X, Chen L, Wei J, Zheng H, et al · · 2025 · cited 39× · PMID 40404619 · DOI 10.1038/s41392-025-02220-z
Verify or expand the search:
- PubMed search for NCT02996318
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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
- NCT03242096 — Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon · NA · completed
- NCT03332264 — Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions · 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 NCT02996318 (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/NCT02996318.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing