Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT05258318
Status:
WITHDRAWN
Last Update Posted:
2025-06-18
First Post:
2022-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Double Rewire Versus Double Kissing Crush Stenting Technique in Left Main Bifurcation Lesions
Sponsor:
Fundación EPIC
Organization:
Study Overview
Official Title:
Double Rewire Versus Double Kissing Crush Stenting Technique in Left Main Bifurcation Lesions
Status:
WITHDRAWN
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DR vs DK crush
Brief Summary:
The DR vs DK trial is designed to elucidate the benefits of Double Rewire crush technique (DR-Crush) over Double Kissing Crush (DK-Crush) technique in patients with Unprotected Left Main Bifurcation lesions (ULMb).
Detailed Description:
DR vs DK is a multicentre, randomized, prospective, non-inferiority clinical trial designed to evaluate the efficacy and safety of DR crush over DK crush for patients with ULMb. More than 12 tertiary centres from Spain will participate including patients. Subjects with Medina 1,1,1 ULMb will be randomized in a 1:1 fashion to DR or DK crush. In order to avoid bias, the Sirolimus coronary stent will be used in all patients (UltimasterTM TanseiTM). The use of Intracoronary imaging techniques are recommended. The primary endpoint is target lesion failure (TLF) including target vessel myocardial infarction, cardiac death and TLR. Other endpoints address individual event of primary end-point, and target vessel revascularization. The safety objective is the ST. Recruitment began in January 2022 and will be completed in January 2024; 180 patients will be randomized.
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?: