The Study of Active Transfer of Plaque Technique for Non-Left Main Coronary Bifurcation Lesions

Beijing Anzhen Hospital316 enrolled

Overview

A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary Bifurcation Lesions.

A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary Bifurcation Lesions. The purpose of this trial is to evaluate the efficacy and safety of Active Transfer of Plaque and provisional T stenting techniques treating non-left-main coronary bifurcation lesions based on TLR rate 12-months post-procedure. Provisional T Stenting is a common technique in BL treatment. Active Transfer of Plaque or ATP was reported, but there are no comparison between two procedure. In the ATP treatment of bifurcation lesions, two wires are advanced to distal main vessel (MV) and side branch(SB). Stent and balloon are advanced to MV and SB respectively. The MV stent is released while dilating the SB balloon. By predilating the balloon in the target SB, the plaque will be actively transferred from SB to MV. Subsequently, the plaque will be fixed by the expansive stent in MV.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. Predilation is left at operator's discretion, however, predilating 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\>75%, \>type B dissection and TIMI flow\<3. All patients will be followed clinically at 1-, 6- 12- and 24-month after stent implantation. Repeat angiographic follow-ups are recommended for all patients at 12 months after the index procedure. The primary endpoint of the trial is the rate of TLR at 12-month follow-up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

316

Conditions

Coronary Heart Disease

Interventions

Sirolimus Drug-eluting Stent via Active Transfer of PlaquePROCEDURE

Sirolimus Drug-eluting Stent implantation via Provisional T StentingPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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. * Non-left-main coronary bifurcation lesion. (Medina 0,1,1;1,1,1;1,0,1;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. * Patient with severe calcified lesions needing rotational atherectomy. * Lesions of in-stent restenosis. * Patients not eligible for this trial based on investigators' judgement.

Outcomes

Primary Outcomes

Target lesion revascularization(TLR) rate at 12 months post-procedure

Time frame: 12 months

Secondary Outcomes

Rate of target lesion failure (TLF) at 30days, 6 months, and 24 months, including cardiac death, MI and ischemic TLR.

Time frame: Up to 2 years

Clinically cardiovascular endpoints at 1-, 6- , 12- and 24-month, including all-cause death, MI and TLR.

Time frame: Up to 2 years

Stent thrombosis which is defined according to Academic Research Consortium (ARC) definition, including definite, probable and possible stent thrombosis.

Time frame: Up to 2 years

New York Heart Association classification of cardiac function.

Time frame: Up to 2 years

Classification score of Canadian Cardiovascular Society (CCS) angina or Braunwald class.

Time frame: Up to 2 years

In-stent lumen late loss, in-segment and in-stent restenosis rate 12 months after procedure

Time frame: 12 months

Data from ClinicalTrials.gov

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