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DK CRUSH-V Clinical Study
Protocol
ChiCTR-TRC-11001213[http://www.chictr.org]
Study Name |
Double Kissing and Double Crush versus Provisional T Stenting Using Everolimus-Eluting Cobalt Chromium Stent for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-center Clinical Trial |
Purpose |
Compare essential functional, angiographic variables and clinical outcomes in patients with unprotected distal left main true bifurcation (LMb) lesions, treated by DK crush versus provisional T stenting using drug-eluting stent (DES) |
Study Design |
A Randomized, International, Multi-center Clinical Trial |
Patient |
A total of 544 patients will be included in the study. |
Patient Follow-up |
All patients will be seen at the outpatient clinic of the participating centers after 1-, 6- , 12- and 24-month. The outpatient visit may be substituted with a telephone contact and subsequent investigational documentation forms. |
Primary Endpoint |
Rate of TLR at 12-month |
Secondary endpoint |
Combined endpoint of all-cause death, MI, TVR at 1- and 2-year |
Other registered outcome parameters |
Procedure related biomarker release |
Inclusion Criteria |
Patient must be at least ≥18, ≤80 years of age. |
Exclusion Criteria |
Patient with STEMI (within 24-hour from the onset of chest pain to admission). |
Safety |
For safety reason, stent thrombosis after one month(late stent thrombosis) will be monitored continuously. A 1-year rate of definite very late stent thrombosis exceeding 5% in the any group will necessitate premature termination of the study. |
Randomization Procedure |
The patients will be randomized after angiography to either DK or T group. The randomization serial number for patients will be performed by Interactive Web Randomization System (IWRS). The randomization serial number for each participating center will be undergone by the same system. |
Sample Size Calculation |
The study is planned as a superiority study, where an experimental treatment of a disease (E, here DK) is compared to a standard treatment (S, here T). Calculations are based on the following: |