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Hydroxyapatite Active Pro Healing Clinical Trial Program

NCT00474084 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2007-05-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Intravascular Coronary Stent

Sponsors & Collaborators

  • MIV Therapeutics Inc.

    collaborator INDUSTRY

  • Cardialysis BV

    collaborator INDUSTRY

  • BioSync Scientific Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Patrick W Serruys, PhD · Erasmus MC Thoraxcentrum, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00474084 on ClinicalTrials.gov