Last reviewed · How we verify
NCT03634020
DynamX Sirolimus Study Sirolimus Eluting Coronary Bioadaptor System
NA trial testing DynamX Sirolimus-eluting Coronary Bioadaptor System in Coronary Artery Disease in 44 participants. Completed in 8 March 2021.
8 March 2021
Quick facts
| Lead sponsor | Elixir Medical Corporation |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 10 December 2018 |
| Primary completion | 8 March 2021 |
| Estimated completion | 8 March 2021 |
| Sites | 7 locations across New Zealand |
Drugs / interventions tested
- DynamX Sirolimus-eluting Coronary Bioadaptor System
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
Sponsor
Elixir Medical Corporation
Who can join
Adults 18 to 80, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To confirm the safety and performance of the DynamX Sirolimus-eluting Coronary Bioadaptor System (SECBS) in de novo native coronary artery lesions using clinical and imaging endpoints. Clinical follow-up will be conducted in all patients at 30 days, 6 and 12 months. Imaging follow-up will be conducted at 6 months.
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 NCT03634020
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Elixir Medical Corporation trials
Trials by the same sponsor.
- NCT05828173 — A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter · NA · completed
- NCT04192747 — The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries · NA · active not recruiting
- NCT04483791 — DynamX Bioadaptor Hong Kong Registry · Phase 4 · completed
- NCT04562805 — Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT) · NA · active not recruiting
- NCT04375085 — DESyne X2 Post Market Follow-up Study · NA · terminated
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 NCT03634020 (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 Elixir Medical Corporation
- Last refreshed: 26 April 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/NCT03634020.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing