Clinical trial NCT02127138: The Study of Active Transfer of Plaque Technique for Unprotected Distal Left Main Bifurcation Lesions
Official title: A Prospective Multicenter 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Keywords: unprotected distal left main bifurcation lesion
Percutaneous coronary intervention
clinical study
Active Transfer of Plaque （ATP）
Provisional T Stenting
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Jishuitan Hospital
name: Tianjin First Central Hospital
name: Tianjin Chest Hospital
name: Taihe Hospital
name: The Fourth Affiliated Hospital of Harbin Medical University
name: General Hospital of Ningxia Medical University
name: Tangshan Worker's Hospital
First posted: 2014-04-30
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of target lesion revascularization (TLR) at 12-month.
timeFrame: 12 months
Secondary outcomes:
measure: Rate of target lesion failure(TLF) at 1-, 6-,12- and 24-month after procedure
timeFrame: Up to 2years
measure: Clinically cardiovascular endpoints at 1-, 6- , 12- and 24-month, including all-cause death, MI and any revascularization.
timeFrame: Up to 2 years
measure: Stent thrombosis which is defined according to Academic Research Consortium (ARC) definition, including definite, probable and possible stent thrombosis.
timeFrame: Up to 2 years
measure: Classification score of Canadian Cardiovascular Society (CCS) angina or Braunwald class.
timeFrame: Up to 2 years
measure: The net gain of lumen diameter; in-segment late loss (LL) and ISR of main vessel and side branch at 13-month.
timeFrame: 13 months
Other outcomes:
measure: The release of procedure-related biomarker
timeFrame: baseline
measure: Consumption of devices for surgery procedure
timeFrame: baseline
measure: Amount of contrast agent
timeFrame: baseline
measure: Procedure time
timeFrame: baseline
measure: X-ray exposure time
timeFrame: baseline
measure: X-ray dose
timeFrame: baseline
measure: DAP-total, DAP-record, DAP-fluoro
timeFrame: baseline
measure: contrast induced acute kidney injury (CIAKI)
timeFrame: 3 days after the procedure
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Yujie Zhou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: