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Sponsors and Collaborators: |
BioSync Scientific Pvt. Ltd. MIV Therapeutics Inc. Cardialysis BV |
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Information provided by: | BioSync Scientific Pvt. Ltd. |
ClinicalTrials.gov Identifier: | NCT00474084 |
The purpose of this first feasibility study is to evaluate the performance of Vesta™ & VestaCOR™ (Hydroxy-Apetite coated GenX) stent in de novo native coronary artery lesions. This study will provide the longest follow-up experience available.
This is a randomized, double blind study conducted at three sites, two sites in India and one in The Netherlands. To be eligible, a patient will be required to have a de novo stenotic lesion of a length that could be covered by a single stent in a native coronary artery of diameter 3.0mm and 3.5mm. A total of at least 60 patients and a maximum of 70 patients will be treated with Vesta™ & VestaCOR™ stent. These patients will be randomized to either a smooth surface nanofilm coated stent (= VestaCOR™) (approx. 35 patients) or to a porous coated stent (= Vesta™) (approx. 35 patients).
All patients will be followed clinically at 30 days, 4 months, 9 months, 1, 2, 3, 4 and 5 years.
Condition | Intervention |
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Coronary Artery Disease |
Device: Intravascular Coronary Stent |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | First In Man Evaluation of the Vesta™ & VestaCOR™ (Hydroxy-Apetite Coated genX™) Stent for Treatment of de Novo Native Coronary Artery Lesion(s) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rohit Chand, BS | +91 9909409606 | rohitchand@gmail.com |
Principal Investigator: | Patrick W Serruys, PhD | Erasmus MC Thoraxcentrum, The Netherlands |
Study ID Numbers: | HAP/CT/01 |
Study First Received: | May 15, 2007 |
Last Updated: | May 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00474084 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Stent Hydroxyapatite Coronary Artery Stenosis Angioplasty |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases |
Constriction, Pathologic Arteriosclerosis Ischemia Coronary Stenosis Coronary Artery Disease |
Cardiovascular Diseases |