Clinical trial NCT02768116: The Study of Active Transfer of Plaque Technique for Non-Left Main Coronary Bifurcation Lesions
Official title: A Prospective Multicenter Randomized Trial Comparing Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary Bifurcation Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Active Transfer of Plaque
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2016-05-11
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 Non-Left-Main Coronary Bifurcation Lesions.

Detailed description: 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.

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.
* 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.

Primary outcomes:
measure: Target lesion revascularization(TLR) rate at 12 months post-procedure
timeFrame: 12 months
Secondary outcomes:
measure: Rate of target lesion failure (TLF) at 30days, 6 months, and 24 months, including cardiac death, MI and ischemic TLR.
timeFrame: Up to 2 years
measure: Clinically cardiovascular endpoints at 1-, 6- , 12- and 24-month, including all-cause death, MI and TLR.
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: New York Heart Association classification of cardiac function.
timeFrame: Up to 2 years
measure: Classification score of Canadian Cardiovascular Society (CCS) angina or Braunwald class.
timeFrame: Up to 2 years
measure: In-stent lumen late loss, in-segment and in-stent restenosis rate 12 months after procedure
timeFrame: 12 months
Other outcomes:
measure: Procedure success rate
timeFrame: Immediately after procedure
measure: Amount of contrast agent
timeFrame: Immediately after procedure
measure: Procedure time
timeFrame: Immediately after procedure
Locations:
Study officials:
affiliation: Beijing Anzhen Hospital
name: Yujie Zhou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: