Safety and efficacy of a bioresorbable vascular scaffold for the side branch in coronary bifurcation lesions: A clinical feasibility trial

Safety and efficacy of a bioresorbable vascular scaffold for the side branch in coronary bifurcation lesions: A clinical feasibility trial - A bioresorbable vascular scaffold for the side branch in coronary bifurcation lesions

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016726

Enrollment

100

Registered

2015-03-08

Start date

2015-03-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease with bifurcation lesions

Interventions

Everolimus-eluting BVS (Absorb, Abbott Vascular)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients or substitute decision-makers willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence (2) Patients eligible for percutaneous coronary intervention (3) Patients with coronary bifurcation stenosis (4) Patients with the necessity of stenting in the side branch after kissing balloon technique during provisional stenting (5) Visually estimated target lesion reference vessel diameter, 2.5-3.75mm and lesion length,<=24 mm in the side branch (6) Patients who can take double antiplatelet agents for 12 months

Exclusion criteria

Exclusion criteria: (1)Unable to be followed up by the implementing medical institution (2)Life expectancy <2 years (3)Allergic or contraindicative to the materials used for BVS (4)Scheduled for elective treatment requiring antiplatelet drug withdrawal (5)Possibility of pregnancy or lactation (6)Deemed as unsuitable by the investigator or sub-investigator

Design outcomes

Primary

Measure	Time frame
The late loss of the side branch in bifurcation at 8 and 20 months after PCI.	—

Countries

Japan

Contacts

Public ContactYasushi Fuku

Public interest incorporated foundation Ohara HealthCare Foundation Department of Cardiology

fuku@kchnet.or.jp086-422-0210

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026