Hydroxyapatite Active Pro Healing Clinical Trial Program

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00474084

Acronym

HApFIM

Enrollment

Registered

2007-05-16

Start date

2007-07-31

Completion date

Unknown

Last updated

2007-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Stent, Hydroxyapatite, Coronary Artery Stenosis, Angioplasty

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.

Interventions

DEVICEIntravascular Coronary Stent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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	4 & 12 months

Contacts

Primary ContactRohit Chand, BS

rohitchand@gmail.com+91 9909409606

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026