Last updated: February 3, 2023
Sponsor: Zuyderland Medisch Centrum
Overall Status: Active - Recruiting
Phase
N/A
Condition
Coronary Artery Disease
Vascular Diseases
Cardiac Surgery
Treatment
N/AClinical Study ID
NCT03562572
17-T-142
28708
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients aged between 18-85 years presenting with non-STEMI according to currentguidelines, who will be treated with PCI of the culprit and have at least one stenosisof >50% in a non-IRA on QCA or visual estimation of baseline angiography and judgedfeasible for treatment with PCI by the operator.
- Non-IRA stenosis amenable for PCI treatment (operator's decision)
- Signed informed consent
Exclusion
Exclusion Criteria:
- Left main disease (stenosis > 50%)
- Chronic total occlusion of a non-IRA
- Indication for or previous coronary artery bypass grafting
- Uncertain culprit lesion
- Complicated IRA treatment, e.g. extravasation, permanent no re-flow after IRAtreatment (TIMI flow 0-1) and inability to implant a stent
- Known severe cardiac valve dysfunction that will require surgery or TAVI in thefollow-up period.
- Killip class III or IV during the completion of culprit lesion treatment.
- Life expectancy of < 1 year.
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor or Heparin.
- Gastrointestinal or genitourinary bleeding within the prior 3 months.
- Planned elective surgical procedure necessitating interruption of thienopyridinesduring the first 6 months post enrolment.
- Patients who are actively participating in another drug or device investigationalstudy, which have not completed the primary endpoint follow-up period.
- Pregnancy
Study Design
Total Participants: 476
Study Start date:
June 07, 2018
Estimated Completion Date:
January 01, 2028
Study Description
Connect with a study center
Brno University Hospital
Brno,
CzechiaActive - Recruiting
Gottsegen György Országos Kardiológiai Intézet
Budapest,
HungaryActive - Recruiting
Bacs-Kiskun Teaching Hospital
Kecskemét,
HungaryActive - Recruiting
Szeged University
Szeged,
HungaryActive - Recruiting
Jeroen Bosch Ziekenhuis
Den Bosch,
NetherlandsActive - Recruiting
Zuyderland MC
Heerlen,
NetherlandsActive - Recruiting
Maastricht University Medical Centre
Maastricht,
NetherlandsActive - Recruiting
Viecuri Medisch Centrum
Venlo,
NetherlandsActive - Recruiting
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