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

NCT02127138 | Unknown

• 1 other identifier: ATP 01
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Heart Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of target lesion revascularization (TLR) at 12-month.

  12 months

Secondary Outcomes (5)

• 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

• 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

• 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 Outcomes (8)

• The release of procedure-related biomarker

  baseline

• Consumption of devices for surgery procedure

  baseline

• Amount of contrast agent

  baseline

Study Arms (2)

ATP technique

EXPERIMENTAL

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

Provisional T stenting technique

ACTIVE COMPARATOR

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

Interventions

Sirolimus eluting Drug stent DEVICE

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.

ATP technique; Provisional T stenting technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Beijing Jishuitan Hospital: collaborator
• Tianjin First Central Hospital: collaborator
• Tianjin Chest Hospital: collaborator
• Taihe Hospital: collaborator
• The Fourth Affiliated Hospital of Harbin Medical University: collaborator
• General Hospital of Ningxia Medical University: collaborator
• Tangshan Worker's Hospital: collaborator

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yujie Zhou, MD, PhD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 27, 2014
• First Posted: April 30, 2014
• Study Start: May 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

CN (1)