Hydroxyapatite Active Pro Healing Clinical Trial Program (HApFIM)

May 15, 2007 updated by: BioSync Scientific Pvt. Ltd.

First In Man Evaluation of the Vesta™ & VestaCOR™ (Hydroxy-Apetite Coated genX™) Stent for Treatment of de Novo Native Coronary Artery Lesion(s)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is  18 years old
  • Patient is eligible for percutaneous coronary intervention (PCI)
  • Patient is an acceptable candidate for CABG
  • Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris ((Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
  • The target lesion is a single de novo coronary artery lesion with 50 and 100% stenosis in one of the major epicardial territories (LAD, LCX or RCA). A second target lesion in another major epicardial vessel could be treated and this second lesion should fit with inclusion/exclusion criteria and will receive the same type of stent.
  • The target lesion must be covered by one study stent preferably with a margin of at least 4mm on each side of the lesion
  • The target lesion length should be ≤ 11 mm
  • The target reference vessel diameter must be  3.0mm and  3.5mm
  • Patient or the patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site

Exclusion Criteria:

  • Female of childbearing potential
  • Documented left ventricular ejection fraction (LVEF) 30%
  • Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure, unless the CK and CK-MB enzymes are less than twice the Upper Normal Limit
  • Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Stainless Steel , contrast agent (that cannot be adequately pre-medicated) or drugs similar to hydroxyapatite
  • A platelet count 100,000 cells/mm3 or 700,000 cells/mm3 or a WBC 3,000 cells/mm3
  • Acute or chronic renal dysfunction (creatinine 2.0 mg/dl or 150µmol/L)
  • Total occlusion (TIMI 0 or 1 (one))
  • Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment;
  • Previous bare metal stenting (less than 1 year) anywhere within the target vessel
  • Previous drug-eluting stenting anywhere within the target vessel;
  • The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
  • Significant (50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
  • Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated
  • Target lesion is located in or supplied by an arterial or venous bypass graft
  • Ostial target lesion
  • Target lesion involves a side branch 2.0mm in diameter with an ostial disease
  • Patient is currently participating in an investigational drug or device study
  • Within 30 days prior procedure patient has undergone a previous coronary interventional procedure of any kind
  • Within 60 days post-procedure patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed
  • Stroke or transient ischemic attack within the prior 6 months
  • Unprotected Left Main (LM) coronary artery disease (stenosis >50%)
  • In the investigator's opinion patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
  • Planned surgery within 6 months after index procedure
  • Life expectancy less than 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-stent late-loss at 4 and 12 months (as measured by QCA), defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiographic MLD
Time Frame: 4 & 12 months
4 & 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioSync Scientific Pvt. Ltd.

Collaborators

Cardialysis BV
MIV Therapeutics Inc.

Investigators

  • Principal Investigator: Patrick W Serruys, PhD, Erasmus MC Thoraxcentrum, The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Study Registration Dates

First Submitted

May 15, 2007

First Submitted That Met QC Criteria

May 15, 2007

First Posted (Estimate)

May 16, 2007

Study Record Updates

Last Update Posted (Estimate)

May 16, 2007

Last Update Submitted That Met QC Criteria

May 15, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAP/CT/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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