Coronary Interventions Ulm - Coronary Chronic Total Occlusions

NCT04650139 | Unknown FDA Device

• 1 other identifier: 0925-0586
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Total Occlusion of Coronary Artery; Chronic Total Occlusion

Outcome Measures

Primary Outcomes (1)

• MACE

  major adverse cardiac event

  1 year

Secondary Outcomes (1)

• TLR

  1 year

Study Arms (2)

successful CTO

Procedure: PCI - percutaneous coronary intervention

non- successful CTO

Procedure: PCI - percutaneous coronary intervention

Interventions

PCI - percutaneous coronary intervention PROCEDURE

percutaneous coronary intervention

Also known as: drug eluting stents, Scaffolds, drug eluting ballons

non- successful CTO; successful CTO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with CTO

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Ulm: lead

Study Sites (1)

University Ulm

Ulm, 89073, Germany

RECRUITING

MeSH Terms

Interventions

Percutaneous Coronary Intervention; Drug-Eluting Stents

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Stents; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: January 1, 2014
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: December 2, 2020

Record last verified: 2020-11

Locations

DE (1)