Coronary Interventions Ulm - Coronary Chronic Total Occlusions

Recruiting

• Conditions: Chronic Total Occlusion of Coronary Artery; Chronic Total Occlusion
• Interventions: Procedure: PCI - percutaneous coronary intervention

• Registration Number: NCT04650139
• Lead Sponsor: University Hospital Ulm

Brief Summary

The aim of the proposed project is to provide the long-term results after a recanalization attempt of chronically occluded coronary arteries.

To investigate recanalization attempt of chronically occluded coronary arteries at the Ulm University Hospital. As shown, it is known that successful recanalization of a chronic occlusion is associated with a lower event rate (reduced mortality and the need for operative myocardial revascularization) compared to unsuccessful recanalization (drug therapy). The standard in the therapy of successfully recanalized chronic occlusions is the use of drug-releasing vascular supports.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Last Update Submitted: 2020-11-24
• Study First Posted: 2020-12-02
• Last Update Posted: 2020-12-02
• Primary Completion: 2024-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients over 18 years

Coronary intervention in chronic coronary artery occlusion

Occlusion > 3 months

Indication for PTCA or recanalization according to guidlines

such as:

Symptoms of the patient

Evidence of myocardial ischemia (stress ECG, scintigraphic

Methods, magnetic resonance imaging, stress echocardiography)

pathological intracoronary flow reserve, prognostic

Exclusion Criteria

• No chronic occlusion,
• Contraindication to anti-platelet therapy

Acetylsalicylic acid plus clopidogrel for at least 3 months such as e.g.

with florid gastrointestinal ulcer disease,

History of hemorrhagic stroke

or urgent non-postponable surgical intervention.

Basic disease with a life expectancy of less than 12 months (here as a rule

no indication for PTCA or reopening available)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
successful CTO	PCI - percutaneous coronary intervention	-
non- successful CTO	PCI - percutaneous coronary intervention	-

Primary Outcome Measures

Name	Time	Method
MACE	1 year	major adverse cardiac event

Secondary Outcome Measures

Name	Time	Method
TLR	1 year	target lesion revascularization

Trial Locations

Locations (1)

University Ulm; 🇩🇪 Ulm, Germany