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

NCT02768116 | Unknown DMC

• 1 other identifier: ATP Trial
• Study Type: interventional
• Target: 316
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Heart Disease

Keywords

Active Transfer of Plaque

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (6)

• 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

Other Outcomes (3)

• Procedure success rate

  Immediately after procedure

• Amount of contrast agent

  Immediately after procedure

• Procedure time

  Immediately after procedure

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 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

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 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

Interventions

Sirolimus Drug-eluting Stent via Active Transfer of Plaque PROCEDURE

ATP technique

Sirolimus Drug-eluting Stent implantation via Provisional T Stenting PROCEDURE

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.
• 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.

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.
• Patient with severe calcified lesions needing rotational atherectomy.
• Lesions of in-stent restenosis.
• Patients not eligible for this trial based on investigators' judgement.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

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: May 9, 2016
• First Posted: May 11, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: January 18, 2020

Record last verified: 2020-01