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NCT04138238
Cruz HBR Registry - Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Stent
trial testing Supraflex Cruz Sirolimus-eluting Stent in Coronary Artery Disease in 1,200 participants. Completed in 31 May 2022.
31 May 2022
Quick facts
| Lead sponsor | Sahajanand Medical Technologies Limited |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,200 |
| Start date | 19 February 2020 |
| Primary completion | 31 May 2022 |
| Estimated completion | 31 May 2022 |
| Sites | 26 locations across France, Switzerland, Germany |
Drugs / interventions tested
- Supraflex Cruz Sirolimus-eluting Stent
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
Sponsor
Sahajanand Medical Technologies Limited — full company profile →
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
This is a prospective, multicenter, open-label, single-arm registry. The primary objective of this registry is to confirm the results of the Supraflex Cruz stent in real life all-comer patients (800 patients as in the Supraflex arm of the TALENT trial) and demonstrate that the Supraflex Cruz stent is not inferior to the BioFreedom stent in High Bleeding Risk (HBR) patients (400 patients) with respect to device oriented composite endpoint (DOCE) at 12 months. All patients will be followed up to 12 months after the index procedure.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04138238
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other Sahajanand Medical Technologies Limited trials
Trials by the same sponsor.
- NCT06507579 — Hydra Registry - UK · recruiting
- NCT06342635 — Hydra Single-centre Experience - Copenhagen, Denmark · recruiting
- NCT05956652 — Hydra Registry - Italy Experience · recruiting
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 NCT04138238 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sahajanand Medical Technologies Limited
- Last refreshed: 12 July 2023
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/NCT04138238.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing