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NCT03721614: Morph RCT-1
Clinical Study Comparing Single Long BioMimeTM Morph Coronary Stent System vs. Two Overlapping Xience Family Coronary Stent Systems in the Treatment of Patients With Long de Novo Lesions.
NA trial testing BioMime™ Morph - Sirolimus Eluting Coronary Stent System in Coronary Artery Disease in 200 participants. Status unknown.
1 December 2021
Quick facts
| Lead sponsor | Meril Life Sciences Pvt. Ltd. |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 15 September 2019 |
| Primary completion | 1 December 2021 |
| Estimated completion | 22 June 2022 |
Drugs / interventions tested
- BioMime™ Morph - Sirolimus Eluting Coronary Stent System
- Xience family Everolimus Coronary Stent Systems
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
Sponsor
Meril Life Sciences Pvt. Ltd.
Who can join
18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A prospective, active control, open-label, multinational, randomized clinical trial comparing single long BioMime™ Morph Coronary Stent System vs. two overlapping Xience family Coronary Stent Systems to evaluate safety and performance in approximately 200 patients with long de novo lesions will be randomly enrolled in a 2:1 ratio \[BioMime™ Morph (n=133) vs. XIENCE family (n=67)\]. The study population should include patients with symptomatic ischemic heart disease due to de novo lesions (lengths ≥26 mm and ≤56 mm irrespective of number of lesions) in native coronary arteries with a reference vessel diameter of (proximal to distal) 2.75 - 2.25 mm, 3.00 - 2.50 mm and 3.5 - 3.00 mm in patients eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) and stenting procedures. All patients must meet all the study inclusion / exclusion criteria before enrolment in the study. All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 24 months post procedure. 10% of the patients \[(2:1) BioMime™ Morph (13) vs. Xience (7)\] will be assessed for OCT analysis from pre-designated site(s) and based on availability of OCT console at the site and Patient's consent. \[Time Frame: Post-procedure and 6 months (±14 days)\]
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Comparison of Contemporary Drug-eluting Coronary Stents - Is Any Stent Better than the Others?
Parker W, Iqbal J. · · 2020 · cited 12× · PMID 36277668 · DOI 10.17925/hi.2020.14.1.34
Verify or expand the search:
- PubMed search for NCT03721614
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Meril Life Sciences Pvt. Ltd. trials
Trials by the same sponsor.
- NCT07532317 — A Prospective, Multinational, Multicentre, Open-label, Randomized Trial to Evaluatesafety and Effectiveness of Meril's M · NA · not yet recruiting
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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 NCT03721614 (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 Meril Life Sciences Pvt. Ltd.
- Last refreshed: 14 August 2019
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/NCT03721614.
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