Coronary artery disease
Conditions
Interventions
1:Angiography guided provisional T stenting
2:Fractional Flow Reserve (FFR) guided provisional T stenting
Sponsors
Nanjing First Hospital, Nanjing Medical Univeristy
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subject must be age 18-75 years; 2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; 3. Subject is eligible for percutaneous coronary intervention (PCI); 4. Subject has Stable/unstable angina or NSTEMI; 5. Subject has STEMI>24-hour from the onset of chest pain to admission; 6. Subject is an acceptable candidate for coronary artery bypass grafting (CABG); 7. Subject is willing to comply with all protocol-required follow-up evaluations; 8. True bifurcation lesions (Medina 0,1,1/1,1,1); 9. Downstrem lesions could be covered by two stents; 10. True bifurcation lesions with CTO lesion in LAD, or LCX or RCA after recanalization; 11. Diameter stenosis >=50% by visual estimation.
Exclusion criteria
Exclusion criteria: 1. Subject with STEMI (within 24-hour from the onset of chest pain to admission); 2. Subject has known allergy to the study stent system (everolimus) or protocol-required concomitant medications; 3. Subject has intolerable to dual anti-platelet therapy; 4. Subject has any other serious medical illness that may reduce life expectancy to less than 12 months; 5. Subject is a women who is pregnant or nursing; 6. Subject has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure; 7. CTO lesion in either LAD, or LCX or RCA unsuccessful recanalization; 8. Severe calcification needing rotational athrectomy; 9. Restenotic from previous intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac events at 12-month; | — |
Secondary
| Measure | Time frame |
|---|---|
| Net gain of lumen diameter;Fractional Flow Reserve (FFR); | — |
Countries
China
Contacts
Public ContactShaoliang Chen
Outcome results
None listed