BioFreedom™ BA9™ Ultra

NCT05331547 | Unknown DMC FDA Device

• 1 other identifier: UW 21-385
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 1.All-cause mortality
2. 2.Cardiovascular death (cardiovascular and undetermined)
3. 3.The composite of cardiovascular death, Target Lesion (TL)-related myocardial infarction and TL-related definite or probable stent thrombosis at one year.
4. 4.Stroke disabling and non-disabling ARC definition
5. 5.Myocardial infarction
6. 6.ARC Stent thrombosis
7. 7.Clinically driven TLR at any follow-up time point
8. 8.Clinically driven target vessel revascularization
9. 9.Any revascularization within 12 months following the index procedure, unless they are planned within the 1st month
10. 10.Bleeding per BARC criteria
11. 11.Restudy angiographic result (QCA)
12. 12.OCT parameters including neointimal volume, neointimal area etc

Conditions

Cardiovascular Death; Myocardial Infarction; Revascularization

Outcome Measures

Primary Outcomes (2)

• Stent strut coverage (degree of endothelialisation)

  Require stage procedure as assessed by optic coherence tomography (OCT) at one month

  At one month

• Target lesion failure (TLF)

  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)

Secondary Outcomes (2)

• BioFreedom Ultra stent at one month

  At one month

• MACE

  Within 12 months

Study Arms (1)

BioFreedom BA9 (SS) Ultra DCS

STEMI patients treated with one or several BioFreedom stent(s)

Device: BioFreedom BA9 (SS) Ultra DCS

Interventions

BioFreedom BA9 (SS) Ultra DCS DEVICE

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

Also known as: optic coherence tomography (OCT)

BioFreedom BA9 (SS) Ultra DCS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A prospective, single center, post marketing registry. We aim to recruit 50 patients. All enrolled patients will be followed up for 12 months.

You may qualify if:

• STEMI patients treated with one or several BioFreedom stent(s)
• Patients who agree to comply with the follow up requirements.
• Patients with a life expectancy of \> 1 year at time of consent.
• Patients eligible to receive dual anti platelet therapy (DAPT). The establishment of the DAPT regimen is at the physician's discretion.

You may not qualify if:

• Patients in cardiogenic shock
• Any out of hospital cardiac arrest
• Glasgow score \< 15
• Patients unable or unwilling to give documented informed consent
• Patients taking part in another interventional trial which has not completed follow-up for the primary endpoint
• Pregnant or breastfeeding women

Sponsors & Collaborators

• The University of Hong Kong: lead
• Biosensors International: collaborator

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Chor Cheung Frankie Tam

CONTACT

852-22553111; Frankie.cctam@gmail.com

Alice Chan

CONTACT

852-22555044; acky@hku.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: April 15, 2022
• Study Start: July 21, 2021
• Primary Completion: July 21, 2022
• Study Completion: January 21, 2024
• Last Updated: April 15, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)