T-provisional Stenting vs Mini-Crush in Chronic Total Occlusions (CTO)

Coronary Artery Disease Clinical Trial

Official title:

Results of T-provisional and Mini Crush Stenting in Patients With Bifurcation Lesions After Chronic Coronary Arteries Occlusions Recanalization: A Prospective Randomized Single-center Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708329
• Other study ID #: TvsMC 1.0
• Status: Completed
• Phase: N/A
• First received: March 9, 2016
• Last updated: March 14, 2016
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2016
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients concidered 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Atherosclerosis
• Coronary Disease
• Coronary Stenosis
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• T-provisional stenting
Standard endovascular T-provisional stenting technique
• Mini-crush stenting
Standard endovascular Mini-crush stenting technique
• CTO coronary angioplasty
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.

Locations

Country	Name	City	State
Russian Federation	State Research Institute of CIrculation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Major adverse cardiac and cerebrovascular events (MACCE)	Major adverse cardiac and cerebrovascular events (MACCE) including: including: All-cause mortality, Myocardial infarction, Stent thrombosis, Clinically indicated Target lesion revascularization, Any target lesion revascularization, Any target vessel revascularization.	During 1 year after procedure	Yes
Secondary	Restenosis of main vessel/side branch	Angiographically estimated main vessel/side branch restenosis. Restenosis is defined as = 50% diameter lumen loss in a target lesion.	At 12-month follow-up	No