The Study of Active Transfer of Plaque Technique for Unprotected Distal Left Main Bifurcation Les… (NCT02127138) | Clinical Trial Compass
UnknownNot Applicable
The Study of Active Transfer of Plaque Technique for Unprotected Distal Left Main Bifurcation Lesions
China316 participantsStarted 2015-05
Plain-language summary
A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must be at least ≥18, ≤80 years of age.
* Patient has Stable/unstable angina or NSTEMI
* Patient has STEMI\>24-hour from the onset of chest pain to admission.
* LMb (Medina 0,1,1ï¼›1,1,1ï¼›0,1,0 ï¼›1,1,0).
* Patient is eligible for elective percutaneous coronary intervention (PCI) .
* Patient is an acceptable candidate for coronary artery bypass grafting (CABG).
* Patient (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; patient is willing to comply with all protocol-required follow-up evaluations
Exclusion Criteria:
* Patient with STEMI (within 24-hour from the onset of chest pain to admission).
* Patient has known allergy to the study stent system or protocol-required concomitant medications that cannot be adequately pre-medicated (everolimus, aspirin, contrast media, acrylic acid, Stainless steel).
* Patient has intolerable to dual anti-platelet therapy.
* Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
* Patient is pregnant or nursing.
* Patient is participating in another clinical trial that has not reached its primary endpoint within 12 months after the index procedure.
* Patient with severe calcified lesions needing rotational atherectomy.
* Left main In Stent Restenosis.
* Investigator consider that patients don't fit to participate in the study.
What they're measuring
1
Rate of target lesion revascularization (TLR) at 12-month.