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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03159650

Enrollment

Registered

2017-05-19

Start date

2017-06-01

Completion date

2019-10-01

Last updated

2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Occlusion

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

Interventions

DEVICEintravascular ultrasonography

intravascular ultrasonography will be used during the study for the resolving proximal cap ambiguity of chronic total occlusion, facilitating re-entry into the true lumen after subintimal crossing and confirming distal true lumen guidewire position

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Contacts

Primary ContactHosam Hasan, professor

hosam_hasan@hotmail.com+20882361015

Backup ContactMohamed karim, assistant professor

m_koriem2004@yahoo.com+201119340685

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026