Hydroxyapatite Active Pro Healing Clinical Trial Program

NCT00474084 | Unknown DMC

• 1 other identifier: HAP/CT/01
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Coronary Artery Disease

Keywords

Stent; Hydroxyapatite; Coronary Artery Stenosis; Angioplasty

Outcome Measures

Primary Outcomes (1)

• 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

  4 & 12 months

Interventions

Intravascular Coronary Stent DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.)

Sponsors & Collaborators

• BioSync Scientific Pvt. Ltd.: lead
• MIV Therapeutics Inc.: collaborator
• Cardialysis BV: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Patrick W Serruys, PhD

  Erasmus MC Thoraxcentrum, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rohit Chand, BS

CONTACT

+91 9909409606; rohitchand@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 15, 2007
• First Posted: May 16, 2007
• Study Start: July 1, 2007
• Last Updated: May 16, 2007

Record last verified: 2007-05