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

A Prospective Multicenter Randomized Trial Comparing 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.

Study Overview

• Status: Unknown
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Procedure: Sirolimus Drug-eluting Stent via Active Transfer of Plaque; Procedure: Sirolimus Drug-eluting Stent implantation via Provisional T Stenting

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.

• Study Type: Interventional
• Enrollment (Anticipated): 316
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATP technique; This arm plan to enroll 158 subjects. Sirolimus-eluting Drug stent implantation via Active transfer of Plaque technique in the treatment of non-left-main bifurcation lesion.In the ATP technique 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. 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 or stent in SB is recommended if there is at least one of following: residual stenosis>75%, >type B dissection and TIMI flow<3.	Procedure: Sirolimus Drug-eluting Stent via Active Transfer of Plaque
Active Comparator: Provisional T stenting technique; This arm plan to enroll 158 subjects. Sirolimus-eluting Drug stent implantation via Provisional T stenting technique in the treatment of non-left-main bifurcation lesions.Provisional T stenting technique 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>75%, >type B dissection and TIMI flow<3.	Procedure: Sirolimus Drug-eluting Stent implantation via Provisional T Stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Target lesion revascularization(TLR) rate at 12 months post-procedure	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of target lesion failure (TLF) at 30days, 6 months, and 24 months, including cardiac death, MI and ischemic TLR.	Up to 2 years
Clinically cardiovascular endpoints at 1-, 6- , 12- and 24-month, including all-cause death, MI and TLR.	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
New York Heart Association classification of cardiac function.	Up to 2 years
Classification score of Canadian Cardiovascular Society (CCS) angina or Braunwald class.	Up to 2 years
In-stent lumen late loss, in-segment and in-stent restenosis rate 12 months after procedure	12 months

Other Outcome Measures

Outcome Measure	Time Frame
Procedure success rate	Immediately after procedure
Amount of contrast agent	Immediately after procedure
Procedure time	Immediately after procedure

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Principal Investigator: Yujie Zhou, MD, PhD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Active Transfer of Plaque
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: ATP Trial