Comparative Study Between Intravascular Ultrasonography Guided and Angiography-guided Recanalization of Coronary Chronic Total Occlusions

Not Applicable

• Conditions: Coronary Occlusion
• Interventions: Device: intravascular ultrasonography

• Registration Number: NCT03159650
• Lead Sponsor: Assiut University

Brief Summary

Chronic total occlusion is defined as thrombolysis in myocardial infarction (TIMI) flow grade 0 with an estimated duration of at least 3 months. The interest in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has increased, but with failure rate up to 20%, leading to important developments in dedicated equipment and techniques.

In the 2014 European Guidelines on Myocardial Revascularization, intravascular ultrasound was recommended to guide stent implantation in selected patients, and this recommendation was a class IIa/level of evidence B.

In CTO PCI, certain angiographic features such as blunt proximal CTO cap, tortuosity, heavy calcification, and lack of visibility of path in the distal vessel increase procedural difficulty

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-17
• Last Update Submitted: 2017-05-17
• Study First Posted: 2017-05-19
• Last Update Posted: 2017-05-19
• Study Start: 2017-06-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• patients with coronary angiography showing chronic coronary total

Exclusion Criteria

1. Acute coronary syndrome within 3 months.
2. Patients with previous coronary artery bypass graft (CABG).
3. Patients with known renal insufficiency (eGFR < 60 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL, or on dialysis).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravascular ultrasonography guided	intravascular ultrasonography	-
Angiography guided	intravascular ultrasonography	-

Primary Outcome Measures

Name	Time	Method
outcomes of intravascular ultrasound guided re-canalized CTO during the procedure and composite of cardiac death, myocardial infarction, or target vessel revascularization	6 months	the study will assess the composite of cardiac death, myocardial infarction, or target vessel revascularization, rehospitalization, coronary artery bypass surgery and stroke within both groups