Phase
Condition
Myocardial Ischemia
Thrombosis
Cardiovascular Disease
Treatment
Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient has chronic stable angina, acute coronary syndromes or silent ischemia;
- Presence of one or more coronary artery stenoses of ≥50% (by visual assessment) in anative coronary artery (with or without prior stent/other device treatment) or in asaphenous venous or arterial bypass conduit suitable for coronary stent implantation;
- The vessel should have a reference vessel diameter of at least 2.25 mm by visualassessment (no limitation on the number of treated lesions, vessels, or lesionlength);
- Patient has been informed of the nature of the study and agrees to its provisions andhas provided written informed consent as approved by the Ethical Committee and iswilling to comply with all protocol-required (follow-up) evaluations.
Exclusion
Exclusion Criteria:
- Patient is a woman who is pregnant or nursing (a pregnancy test must be performedwithin 7 days prior to the index procedure in women of child-bearing potentialaccording to local practice);
- Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin,heparin, bivalirudin or P2Y12 inhibitors;
- Planned major elective surgery requiring discontinuation of (dual)anti platelettherapy (DAPT) within 12 months of procedure;
- Concurrent medical condition with a life expectancy of less than 3 years;
- Currently participating in another trial and not yet at its primary endpoint;
- Active pathological bleeding;
- History of intracranial haemorrhage.
Study Design
Connect with a study center
ASZ Aalst
Aalst,
BelgiumActive - Recruiting
OLVZ Aalst
Aalst,
BelgiumActive - Recruiting
Imelda Ziekenhuis
Bonheiden,
BelgiumActive - Recruiting
Imeldaziekenhuis
Bonheiden,
BelgiumActive - Recruiting
CHU Charleroi
Charleroi,
BelgiumActive - Recruiting
Jessa Hospital Hasselt
Hasselt,
BelgiumActive - Recruiting
University Hospital Galway
Galway,
IrelandActive - Recruiting
OLVG Amsterdam
Amsterdam,
NetherlandsActive - Recruiting
Medisch Spectrum Twente, Thoraxcentrum, Endchede
Endchede,
NetherlandsSite Not Available
Medisch Spectrum Twente, Thoraxcentrum, Endchede
Enschede,
NetherlandsActive - Recruiting
UMC Groningen
Groningen,
NetherlandsActive - Recruiting
Den Haag Ziekenhuis
Hague,
NetherlandsActive - Recruiting
Medisch Centrum Leeuwarden
Leeuwarden,
NetherlandsActive - Recruiting
Maasstad Hospital
Rotterdam,
NetherlandsSite Not Available
Maasstad Ziekenhuis
Rotterdam,
NetherlandsActive - Recruiting
Hospital Clínico de Barcelona
Barcelona,
SpainActive - Recruiting
Lucas Augusti Hospital
Lugo,
SpainActive - Recruiting
Hospital Clínico San Carlos
Madrid,
SpainSite Not Available
Hospital Clínico Universitario of Valladolid
Valladolid,
SpainActive - Recruiting
Hospital Álvaro Cunqueiro Vigo
Vigo,
SpainActive - Recruiting
Hospital Álvaro Cunqueiro Vigo.
Vigo,
SpainSite Not Available
Barts Health NHS Trust, London
London,
United KingdomActive - Recruiting
Freeman Hospital
Newcastle,
United KingdomActive - Recruiting
University Hospitals Southampton
Southampton,
United KingdomActive - Recruiting
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