Coronary Interventions Ulm - Coronary Chronic Total Occlusions

Chronic Total Occlusion of Coronary Artery Clinical Trial

— CSI  

Official title:

Coronary Interventions Ulm - Coronary Chronic Total Occlusions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04650139
• Other study ID #: 0925-0586
• Status: Recruiting
• Start date: January 1, 2014
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2020
• Source: University Hospital Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Total Occlusion
• Chronic Total Occlusion of Coronary Artery

Intervention

Procedure:
• PCI - percutaneous coronary intervention
percutaneous coronary intervention

Locations

Country	Name	City	State
Germany	University Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	major adverse cardiac event	1 year
Secondary	TLR	target lesion revascularization	1 year