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NCT05331547
BioFreedom™ BA9™ Ultra
trial testing BioFreedom BA9 (SS) Ultra DCS in Cardiovascular Death in 50 participants. Status unknown.
21 July 2022
Quick facts
| Lead sponsor | The University of Hong Kong |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 21 July 2021 |
| Primary completion | 21 July 2022 |
| Estimated completion | 21 January 2024 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- BioFreedom BA9 (SS) Ultra DCS
Conditions studied
- Cardiovascular Death — all drugs for Cardiovascular Death →
- Myocardial Infarction — all drugs for Myocardial Infarction →
- Revascularization — all drugs for Revascularization →
Sponsor
The University of Hong Kong
Who can join
Eligibility, any sex, with Cardiovascular Death or Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the study is to assess the safety and efficacy of the BioFreedom Ultra stent for treatment of STEMI patients. Besides, in patients who are clinically indicated for a stage procedure, Investigators aim to assess the angiographic and endovascular healing of BioFreedom Ultra stent at one month This is a prospective, single center, post marketing registry. Investigators aim to recruit 50 patients. All enrolled patients will be followed up for 12 months. Restudy Subgroup For subjects who are clinically indicated for staged procedure, they will be recruited into restudy subgroup. Restudy angiogram of target lesion will be performed at 28 (±7) days. Intravascular OCT will be performed. The primary endpoint is target lesion failure (TLF) defined as composite of cardiovascular death, target-vessel related myocardial infarction (Q-wave and non-Q-wave), or ischemia-driven target lesion revascularization within 12 months (device-oriented outcome per ARC definitions) The co-primary endpoint in subjects who require stage procedure is stent strut coverage (degree of endothelialisation) as assessed by optic coherence tomography (OCT) at one month Secondary endpoints include 1. All-cause mortality 2. Cardiovascular death (cardiovascular and undetermined) 3. The composite of cardiovascular death, Target Lesion (TL)-related myocardial infarction and TL-related definite or probable stent thrombosis at one year. 4. Stroke disabling and non-disabling ARC definition 5. Myocardial infarction 6. ARC Stent thrombosis 7. Clinically driven TLR at any follow-up time point 8. Clinically driven target vessel revascularization 9. Any revascularization within 12 months following the index procedure, unless they are planned within the 1st month 10. Bleeding per BARC criteria For subjects in restudy subgroup 11. Restudy angiographic result (QCA) 12. OCT parameters including neointimal volume, neointimal area etc
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05331547
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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 NCT05331547 (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 The University of Hong Kong
- Last refreshed: 15 April 2022
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/NCT05331547.
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