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BioFreedom™ BA9™ Ultra

NCT05331547 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-04-15

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

BioFreedom BA9 (SS) Ultra DCS

BioFreedom Ultra stent for treatment of STEMI patients. Besides, in patients who are clinically indicated for a stage procedure, we aim to assess the angiographic and endovascular healing of BioFreedom Ultra stent at one month

Sponsors & Collaborators

  • Biosensors International

    collaborator OTHER

  • The University of Hong Kong

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2022-07-21
Completion
2024-01-21
FDA Device
Yes

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05331547 on ClinicalTrials.gov