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

Assiut University

Status: Unknown

Conditions: Coronary Occlusion

Treatments: Device: intravascular ultrasonography

Study type: Interventional

Funder types: Other

Identifiers

NCT03159650

IVUSAN

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

intravascular ultrasonography guided

Experimental group

Treatment:

Device: intravascular ultrasonography

Angiography guided

Active Comparator group

Treatment:

Device: intravascular ultrasonography