NCT02708329

Brief Summary

The aim is to compare the results of using T-provisional and Mini-Crush stenting techniques in patients with bifurcation lesions in the CTO segment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

1.9 years

First QC Date

March 9, 2016

Last Update Submit

May 8, 2016

Conditions

Ischemic Heart DiseaseCoronary AtherosclerosisCoronary Artery DiseaseCoronary Artery Stenosis

Keywords

Coronary stenosisDrug-eluting stentCoronary angioplasty with stentingIschemic Heart DiseaseChronic total occlusionBifurcational lesionBifurcational stenting

Outcome Measures

Primary Outcomes (1)

  • Target lesion failure

    Primary outcome is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.

    During 1 year after procedure

Secondary Outcomes (2)

  • Major adverse cardiac and cerebrovascular events (MACCE)

    During 1 year after procedure

  • Restenosis of main vessel/side branch

    At 12-month follow-up

Study Arms (2)

CTO coronary angioplasty +T-provisional stenting

ACTIVE COMPARATOR

Coronary angioplasty using T-provisional stenting in patients with bifurcational lesion in Chronic total occlusion segment.

Procedure: T-provisional stentingProcedure: CTO coronary angioplasty

CTO coronary angioplasty + Mini-crush stenting

EXPERIMENTAL

Coronary angioplasty using Mini-crush stenting in patients with bifurcational lesion in Chronic total occlusion segment.

Procedure: Mini-crush stentingProcedure: CTO coronary angioplasty

Interventions

T-provisional stentingPROCEDURE

Standard endovascular T-provisional stenting technique

CTO coronary angioplasty +T-provisional stenting
Mini-crush stentingPROCEDURE

Standard endovascular Mini-crush stenting technique

CTO coronary angioplasty + Mini-crush stenting
CTO coronary angioplastyPROCEDURE

A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Recanalisation of coronary artery CTO is performed by the hydrophilic coronary wire, using the most appropriate technique. Then balloon angioplasty of target lesion is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.

CTO coronary angioplasty + Mini-crush stentingCTO coronary angioplasty +T-provisional stenting

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients considered for coronary angioplasty with stenting due to Ischemic heart disease (Stable angina, Unstable angina, non-ST Myocardial Infarction).
  • Bifurcation side branch diameter \>2 mm in CTO segment, verified by coronary angiography
  • Successful CTO recanalization
  • Signed, documented informed consent prior to admission to the study

You may not qualify if:

  • Age \<18 years or \>75 years
  • Left main artery bifurcation lesion
  • Reocclusion CTOs
  • Renal insufficiency (GFR/MDRD \<30 ml/min)
  • Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3.
  • Known non-adherence to double anti-platelet therapy (DAPT)
  • LVEF \<30%
  • Continuing bleeding
  • Acute coronary syndrome (ST-elevation Myocardial infarction)
  • Anamnesis of previous CABG
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute of CIrculation Pathology

Novosibirsk, 630055, Russia

Location

MeSH Terms

Conditions

Myocardial IschemiaCoronary Artery DiseaseCoronary Stenosis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 15, 2016

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

May 10, 2016

Record last verified: 2016-05

Locations

RU(1)