NCT05705362Not yet recruiting
Simple Crossover Versus Side Branch Opening in Patients With Non-Left Main Bifurcation Lesion
Randomized Controlled Trial of Simple CROSSsover Versus Side Branch Opening on Clinical Outcomes in Patients With Non-Left Main BIfurcation LeSion (CROSS-COBIS)
Source: ClinicalTrials.gov · Last updated 30 Jan 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Hypothesis: Simple crossover strategy would be non-inferior to SB opening strategy in the risk of target lesion failure (TLF) in patients with angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion. A total of 1000 patients (500 per each group) with the angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion will be enrolled. Patients will be randomized to either the simple crossover strategy group or SB opening strategy group at the time of enrollment with 1:1 ratio. Stratified randomization according to participating center, clinical presentation (acute coronary syndrome or stable ischemic heart disease), and type of bifurcation lesions (true or non-true) will be performed.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 19 Dec 2022
- Start date
- 1 Mar 2023
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT05705362
What you commit to
- Study type: Interventional
- Planned participants: 1000
- From 1 Mar 2023 to the primary completion date, 31 Mar 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- (7) Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
Lab values
- (5) Patients with significant valvular heart disease or severe left ventricular systolic dysfunction (ejection fraction \<35%)
Other
- (1) Target lesions requiring elective 2-stenting technique by operators' decision (Observation Group 1)\*
- (2) Patients who inevitably require SB intervention after MV stenting, as follows. (Observation Group 2)\*
- Reduced SB TIMI flow (≤2) after MV stenting
- SB dissection after MV stenting (≥ Type C)
- (3) Patients without SB compromise after MV stenting (visually SB stenosis \<50%) (Observation Group 3)\*
- (4) Cardiogenic shock (Killip class IV) at presentation
- (6) Pregnancy or breast feeding
- (8) Unwillingness or inability to comply with the procedures described in this protocol
Who the study is looking for
- (1) Subject must be at least 19 years of age
- (2) Patients with non-left main bifurcation lesion (SB diameter ≥2.3 mm)
- (3) Target lesions amenable for 1-stenting with provisional SB approach by operators' decision
- (4) Angiographically compromised SB (visual SB stenosis ≥50%) after provisional MV stenting
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.