Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-01 @ 12:15 AM
Study NCT ID:
NCT04242134
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2020-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
Sponsor:
Nanjing First Hospital, Nanjing Medical University
Organization:
Study Overview
Official Title:
Comparison of Noncompliant Balloon With Drug-coating Balloon Angioplasties for Side Branch After Provisional Stenting for Patients With True Coronary Bifurcation Lesions
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DCB-BIF
Brief Summary:
This study is designed to investigate whether drug-coated balloon (DCB) compared to conventional balloon angioplasty for side branch after provisional stenting will lead to lower rates of the composite endpoint of major adverse cardiac event (MACE) at 12 months. The individual components of MACE include cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). True bifurcation lesions were defined according to Medina classification.
Detailed Description:
This is a prospective, multi-center, randomized-controlled, single blind, superiority trial that will include 25 international sites. The investigators aim to enroll 784 subjects with true coronary bifurcation lesions in native coronary arterial segments.
All patients with true coronary bifurcation lesions suitable for angioplasty will undergo 1:1 randomization either to PS (provisional stenting)-DCB or PS-NCB (noncompliant balloon) group using a randomization schedule blocked by site.
All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo angiography after successful stenting of the main vessel with ostium side branch visually estimated stenosis ≥70%. Data and images will be collected during the index procedure, during re-intervention in the case of clinically driven revascularization, and at the predefined 12-month clinical follow-up visit. All subjects will also undergo angiographic follow-up at 13 months.
All patients with true coronary bifurcation lesions suitable for angioplasty will undergo 1:1 randomization either to PS (provisional stenting)-DCB or PS-NCB (noncompliant balloon) group using a randomization schedule blocked by site.
All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo angiography after successful stenting of the main vessel with ostium side branch visually estimated stenosis ≥70%. Data and images will be collected during the index procedure, during re-intervention in the case of clinically driven revascularization, and at the predefined 12-month clinical follow-up visit. All subjects will also undergo angiographic follow-up at 13 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: