Status:
WITHDRAWN
Double Rewire Versus Double Kissing Crush Stenting Technique in Left Main Bifurcation Lesions
Lead Sponsor:
Fundación EPIC
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 l...
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 ...
Eligibility Criteria
Inclusion
- Patients between 18-90 years of age.
- Patients who gave written informed consent for participation in the trial.
- Lesions are eligible for percutaneous coronary intervention (PCI).
- Patient has stable/unstable angina or myocardial infarction (MI): all-comers.
- ULMb (Medina 1,1,1) with/without left main ostial/shaft lesions. Downstream lesions in LAD or LCX could be covered by two stents. Severe calcification needing rotational atherectomy, orbital atherectomy or Laser are included.
- Diameter stenosis in LAD/LM and LCX ≥ 50% by visual estimation or minimal luminal area by IVUS in LM ≤6 mm2.
Exclusion
- Restenotic lesions.
- Patient was allergic to the study stent or protocol-required concomitant medications.
- Patient is intolerable to dual anti-platelet therapy.
- Patient has any other serious medical illness that may reduce life expectancy to \<12 months.
- Patient is a woman who is pregnant or nursing.
- Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
- Patient is participating in another clinical trial.
- Patients in shock.
Key Trial Info
Start Date :
February 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05258318
Start Date
February 20 2022
End Date
January 1 2024
Last Update
June 18 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.