The Study of Active Transfer of Plaque Technique for Unprotected Distal Left Main Bifurcation Lesions

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

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

Study Overview

• Status: Unknown
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Device: Sirolimus eluting Drug stent

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.

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

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Beijing Anzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 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.
• 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.

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 unprotected distal left main bifurcation lesions.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>70%, >type B dissection and TIMI flow<3.	Device: Sirolimus 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.
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 unprotected distal 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>70%, >type B dissection and TIMI flow<3.	Device: Sirolimus 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of target lesion revascularization (TLR) at 12-month.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Time Frame
The release of procedure-related biomarker	baseline
Consumption of devices for surgery procedure	baseline
Amount of contrast agent	baseline
Procedure time	baseline
X-ray exposure time	baseline
X-ray dose	baseline
DAP-total, DAP-record, DAP-fluoro	baseline
contrast induced acute kidney injury (CIAKI)	3 days after the procedure

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Collaborators: General Hospital of Ningxia Medical University; Tianjin First Central Hospital; Beijing Jishuitan Hospital; Taihe Hospital; Tianjin Chest Hospital; The Fourth Affiliated Hospital of Harbin Medical University; Tangshan Worker's Hospital
• Investigators: Principal Investigator: Yujie Zhou, MD, PhD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 27, 2014
• First Submitted That Met QC Criteria: April 28, 2014
• First Posted (Estimate): April 30, 2014

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: Percutaneous coronary intervention; clinical study; unprotected distal left main bifurcation lesion; Active Transfer of Plaque （ATP）; Provisional T Stenting
• 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 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided