Infinnium-Core™ Registry for the Treatment of Patients With De Novo Coronary Lesions

Coronary Artery Disease Clinical Trial

Official title:

Safety and Efficacy of the Infinnium-Core™ Paclitaxel-Eluting Coronary Stent System for the Treatment of Patients With De Novo Coronary Lesions

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00936780
• Other study ID #: IC001: V1.1
• Status: Terminated
• Phase: Phase 4
• First received: July 8, 2009
• Last updated: August 22, 2012
• Start date: July 2008
• Est. completion date: March 2011

Study information

• Verified date: August 2012
• Source: Sahajanand Medical Technologies Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

The primary objective of Infinnium-Core™ Registry is to assess the safety and efficacy of the Infinnium-Core™ Paclitaxel Eluting Coronary Stent System in de novo Coronary Lesions.

Description:

Infinnium-Core™ Registry is a multi-centric, prospective study. Approximately 150 patients will be enrolled in the study. Patients will be followed for two years post-procedure.

Data analysis will include all statistically pre assigned 20% patients and all patients who have repeat angiography due to complication. The diabetic patients will be specified as a high risk subset in this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years.

2. Eligible for percutaneous coronary intervention (PCI).

3. Acceptable candidate for CABG.

4. 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.

5. 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 the inclusion/exclusion criteria and will receive the same type of stent.

6. The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.

7. The target lesion must be = 37 mm in length by visual estimate.

8. The target reference vessel diameter must be = 2.5 mm and = 3.5 mm.

9. Patient or 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 notified / approved by the Institutional Review Board/Ethics Committee of the clinical site.

Exclusion Criteria:

1. Female of childbearing potential.

2. Documented left ventricular ejection fraction (LVEF) = 25%.

3. Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure.

4. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®, Ceruvin) or ticlopidine (Ticlid®), heparin, paclitaxel, cobalt, chromium, contrast agent (that cannot be adequately pre-medicated).

5. A platelet count <100,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3,000 cells/mm3.

6. Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or > 150 µmol/L).

7. Target vessel has evidence of thrombus.

8. Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment.

9. Previous bare metal stenting (less than 1 year) anywhere within the target vessel.

10. Previous drug-eluting stenting anywhere within any epicardial vessel

11. 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.)

12. Significant (> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off.

13. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated.

14. Target lesion is located in or supplied by an arterial or venous bypass graft.

15. Ostial target lesion.

16. Patient is currently participating in an investigational drug or device study, including its follow-up period.

17. Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind.

18. 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.

19. CVA within previous 6 months.

20. Unprotected Left Main (LM) coronary artery disease (stenosis > 50%).

21. 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.

22. Planned surgery within 6 months after the index procedure.

23. Life expectancy less than 1 year.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Infinnium-Core™ Paclitaxel eluting Coronary Stent
Infinnium-Core™ Coronary Stent System consisting of the Coronnium® coronary stent (CE approved) having Biodegradable Polymeric Matrix on a Co-Cr alloy Platform. Drug concentration is 1.36 µg/mm2.

Locations

Country	Name	City	State
India	Sri Ramakrishna Heart Foundation & Research Centre	Coimbatore	Tamilnadu
India	CHL Apollo Hospitals	Indore	Madhya Pradesh
India	CHL Apollo Hospitals,	Indore.	Madhya Pradesh.
India	Arneja Heart Institute	Nagpur	Maharashtra
India	Government Medical College & Super Speciality Hospital	Nagpur	Maharashtra
India	Bankers Heart Institute	Vadodara	Gujarat
India	Baroda Heart Institute & Research Center	Vadodara	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Sahajanand Medical Technologies Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events (MACE)		30 days and 9 month	Yes
Secondary	ANGIOGRAPHIC	In Angiographic outcome measures the Minimal lumen diameter (MLD), % diameter stenosis, In-Stent and In-segment late loss, Proximal late loss, Distal late loss and Binary restenosis rate	12 months	No