6 eredmények
DEDICATE Registry:
DRUG ELUTING STENT FOR DIABETIC PATIENTS IN CORONARY ARTERY DISEASE TREATMENT
A POST MARKET REGISTRY OF ABLUMINUS® SIROLIMUS ELUTING CORONARY STENT SYSTEM FOR PERCUTANEOUS INTERVENTION IN PATIENTS WITH DIABETES MELLITUS
Version 1.0
Principal Investigator Dr. Luca Testa, MD, PhD
Investigation type: Premarket study to receive a CE marking, followed by post-marketing surveillance follow-up.
Investigation design: Multi-centre, prospective, non-randomized, observational study
Investigation objectives:
The primary objective is to confirm the safety and efficacy of the H1 hip
Patients being treated for metal on metal acetabular revision surgery by a physician at OrthoCarolina, PA will be screened for eligibility. These patients will be approached by their surgeon and asked to volunteer their participation in the study. Potential subjects will meet with a research
Well-functioning MoM implants have shown an increase in serum cobalt and chromium (CoCr) ion levels from the metal debris generated from the implant wear.However, the current evidence suggests that measuring ion levels is unreliable and that increasing ion levels do not correlate with tissue damage.
This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces. Secondary goals include an assessment of osteolysis on radiographs, potential long term