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Vessel Injury in Relation With Strut Thickness Assessed by OCT (VISTA): A Comparison of Vascular Injury Induced by a Polymer Free Sirolimus and Probucol Eluting Stent and a Biodegradable-polymer Biolimus-eluting Stent (NCT03026465)

B.Braun Surgical SA
The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness.
  • Device: Polymer-free stent
    PCI using a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR)
    • Coroflex ISAR
  • Device: Biodegradable-polymer stent
    PCI using a biodegradable-polymer biolimus-eluting stent (Biomatrix)
    • Biomatrix
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • Patients older than 18 years
  • Ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of >50% de novo stenosis located in native coronary vessels
Exclusion Criteria:
  • Target lesion located in the left main stem
  • STEMI
  • Restenosis
  • Cardiogenic shock
  • Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol noncompliance
  • Known allergy to the study medications (probucol, sirolimus, zotarolimus)
  • Pregnancy (present, suspected, or planned)
Thinner struts produce less arterial injury after stent implantation.The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness. Vessel injury after stent implantation will be evaluated with optical coherence tomography (OCT). Two stents platforms with different strut thickness (Coroflex ISAR 50 microns and Biomatrix 120 microns) will be compared.

3 locations

Spain (3)
  • Complejo Hospitalario Universitario de Vigo
    not yet recruiting
    Vigo, Pontevedra, Spain
  • Hospital Clinico San Carlos
    recruiting
    Madrid, Spain, 28040
  • Hospital Universitario de La Princesa
    not yet recruiting
    Madrid, Spain
Status:
recruiting
Type:
Interventional
Phase:
Start:
15 February, 2017
Updated:
15 August, 2017
Participants:
50
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