Status:
COMPLETED
Activity of Platelets After Inhibition and Cardiovascular Events Optical Coherence Tomography Study
Lead Sponsor:
IRCCS San Raffaele
Collaborating Sponsors:
Mediolanum Cardio Research
Cardiovascular Research Foundation, New York
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
It is an exploratory study evaluating a biological effect (stent strut coverage) using a novel technology such as OCT without any clinical implication.
Detailed Description
The question of whether DES are safe, has become an area of considerable interest and controversy with the publication of a relatively small randomized trial (BASKET-LATE), an observational study and ...
Eligibility Criteria
Inclusion
- Diagnosis of ACS and clinical indication to PCI
- Presence of 1 or more de novo stenosis equal or greater than 70% in native coronary arteries.
- Patient is \> 18 years of age (or minimum age as required by local regulations).
- The patient has consented to participate by signing the "Patient Informed Consent Form".
- The patient is willing and able to cooperate with study procedures and required follow up visits.
- Any type of lesion can be included in this trial unless specifically detailed in the exclusion criteria.
- No other stent implanted before in the target lesion
Exclusion
- Patients treated for lesions in venous or arterial grafts.
- Patients treated for in-stent restenosis.
- Patients treated for Unprotected Left Main lesions.
- Patients with left ventricular ejection fraction (LVEF) ≤30%.
- Patients with chronic kidney disease (creatinine ≥1.5 mg/dL) .
- Women with known pregnancy or who are lactating.
- Patients with hypersensitivity or allergies to heparin, drugs such as ABT-578 and everolimus, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
- Contraindication to the use of clopidogrel and/or ASA:
- History of drug allergy to thienopyridine derivatives or ASA;
- History of clinically significant or persistent thrombocytopenia or neutropenia
- Active bleeding or significant risk of bleedings, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
- Current medical condition with a life expectancy of less than 24 months.
- The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this trial.
- Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01239654
Start Date
September 1 2010
End Date
August 1 2011
Last Update
May 23 2012
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Università della Magna Grecia
Catanzaro, Italy, 88100
2
Careggi Hospital
Florence, Italy, 50134
3
San Raffaele Hospital
Milan, Italy, 20132
4
Ospedale Civile di Mirano
Mirano, Italy, 30035