Coronary Heart Disease
Conditions
Keywords
unprotected distal left main bifurcation lesion, Percutaneous coronary intervention, clinical study, Active Transfer of Plaque （ATP）, Provisional T Stenting
Brief 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
Detailed description
It is a prospective, multi-center, randomized, open-label, non-inferiority trial. A total of 316 subjects from around 20 selected hospitals will be randomized on a 1:1 basis to either Active transfer of Plaque (ATP) stenting technique or Provisional T stenting technique. In the ATP treatment of bifurcation lesions, by the balloon pre-dilation in the target side branch, the plaque will be actively transferred from side branch to main vessel. Subsequently, the plaque will be fixed by the expansive stent in main vessel.As to the provisional T treatment, provisional T stenting is the typic step-T stenting. In brief, two wires are advanced to distal MV and SB. Pre dilation is left at operator's discretion, however, pre dilating SB is not encouraged. Kissing balloon inflation before stenting MV is left at operator's discretion. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI is recommended if there is at least one of following: residual stenosis\>70%, \>type B dissection and TIMI flow\<3. All patients will be followed clinically at 1-, 6- 12- and 24-month after stent implantation. Repeat angiography will be performed in all patients at 13 months after the index procedure. The primary endpoint of the trial is the rate of TLR at 12-month follow-up.
Interventions
DEVICESirolimus eluting Drug stent
Use the Sirolimus-eluting Drug stents has been approved by the CFDA，But does not allow use taxol-eluting Drug stents and Drug-eluting stent without Polymer.
Sponsors
Beijing Jishuitan Hospital
Tianjin First Central Hospital
Tianjin Chest Hospital
Taihe Hospital
The Fourth Affiliated Hospital of Harbin Medical University
General Hospital of Ningxia Medical University
Tangshan Worker's Hospital
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 0,1,1；1,1,1；0,1,0 ；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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of target lesion revascularization (TLR) at 12-month. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Rate of target lesion failure(TLF) at 1-, 6-,12- and 24-month after procedure | Up to 2years |
| Clinically cardiovascular endpoints at 1-, 6- , 12- and 24-month, including all-cause death, MI and any revascularization. | Up to 2 years |
| Stent thrombosis which is defined according to Academic Research Consortium (ARC) definition, including definite, probable and possible stent thrombosis. | Up to 2 years |
| Classification score of Canadian Cardiovascular Society (CCS) angina or Braunwald class. | Up to 2 years |
| The net gain of lumen diameter; in-segment late loss (LL) and ISR of main vessel and side branch at 13-month. | 13 months |
Other
| Measure | Time frame |
|---|---|
| DAP-total, DAP-record, DAP-fluoro | baseline |
| The release of procedure-related biomarker | baseline |
| contrast induced acute kidney injury (CIAKI) | 3 days after the procedure |
| Consumption of devices for surgery procedure | baseline |
| Amount of contrast agent | baseline |
| Procedure time | baseline |
| X-ray exposure time | baseline |
| X-ray dose | baseline |
Countries
China
Outcome results
None listed