Coronary Artery DiseaseHApFIMNCT00474084
Hydroxyapatite Active Pro Healing Clinical Trial Program
A study testing Intravascular Coronary Stent in people with Coronary Artery Disease, run by BioSync Scientific Pvt. Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Intravascular Coronary Stent
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet.
About this 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)
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
- Being tested
- Intravascular Coronary Stent
- Keywords
- Stent, Hydroxyapatite, Coronary Artery Stenosis, Angioplasty
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular Coronary StentDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSync Scientific Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MIV Therapeutics Inc., Cardialysis BV
- Investigators
- Patrick W Serruys, PhD, Principal investigator, Erasmus MC Thoraxcentrum, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474084
- Sponsor's protocol ID
- HAP/CT/01
- Acronym
- HApFIM
- Status last verified
- May 2007
- First submitted
- 15 May 2007
- Last updated
- 16 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00474084
- Acronym / sponsor ID
- HApFIM / HAP/CT/01
- Conditions
- Coronary Artery Disease
- Keywords
- Stent, Hydroxyapatite, Coronary Artery Stenosis, Angioplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- BioSync Scientific Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- MIV Therapeutics Inc., Cardialysis BV
- Study start
- Jul 2007
- First posted
- 16 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular Coronary Stent | Device | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick W Serruys, PhD principal investigator
Erasmus MC Thoraxcentrum, The Netherlands
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular Coronary Stent in people with Coronary Artery Disease, run by BioSync Scientific Pvt. Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rohit Chand, BS (+91 9909409606, rohitchand@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2007.