Clinical Trial: Chronic Total Occlusion Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title:

Brief Summary: The aim of this CTO registry is to gather data including patient demographic date, cardiac risk factors, procedural technical data and procedural success/outcome rates. Furthermore, we aim to evaluate the safety and performance of various CTO specific guidewires, devices (such as the CrossBoss/Stingray dissection ren-entry device) and other recognised and approved techniques (retrograde wire escalation, retrograde dissection re-etry techniques). The incidence of recognized complications (dissections, perforations, cardiac tamponade, vascular complications, radiation injury, acute kidney injury) will also evaluated. We will assess clinical outcome at 1 year after succesful CTO procedures.

Detailed Summary:

This objectives of this single-center CTO registry are to:

  1. Gather prospective clinical data on all consecutive patients undergoing complex difficult CTO PCI procedures including including patient demographic date, cardiac risk factors, procedural technical data (contrast volume, radiation exposure, procedure time and procedural success/outcome rates.
  2. Evaluate the safety and performance of various CTO dedicated guidewires, devices (such as the CrossBoss/Stingray anterior dissection re-entry device) and other recognised and approved techniques (retrograde wire escalation, retrograde dissection re-etry techniques).
  3. Evaluate the incidence and severity of recognized complications such as coronary dissections, coronary perforations (+/- need for emergency pericardiocentesis), acute kidney injury, radiation injury, access site vascular complications.
  4. Evaluate the medium-term outcome (recurrence of symptoms, major cardiovascular events (cardiac death, myocardial infarction, target lesion revascularization, target vessel revascularization) during a routine out-patient consultation (planned as part of normal standard care) at 1 year post successful CTO PCI. After this consultation, the patient may choose to have cardiology follow-up at the UZ Leuven or with his/her referring cardiologist.

Sponsor: Universitaire Ziekenhuizen Leuven

Current Primary Outcome: Succes rate of procedure [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Universitaire Ziekenhuizen Leuven

Dates:
Date Received: January 28, 2015
Date Started: January 2015
Date Completion: January 2025
Last Updated: January 28, 2015
Last Verified: January 2015