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XIENCE™ V Everolimus Eluting Coronary Stent System India Post-Marketing Registry (XIENCE V India)

This study is currently recruiting participants.
Verified by Abbott Vascular, August 2008

Sponsored by: Abbott Vascular
Information provided by: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00631228
  Purpose

XIENCE™ V India is a prospective, open-label, multi-center, observational, single-arm registry to evaluate XIENCE™ V EECSS continued safety and effectiveness during commercial use in real world settings.


Condition Intervention Phase
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Device: XIENCE™ V Everolimus Eluting Coronary Stent
Phase IV

MedlinePlus related topics:   Coronary Artery Disease   

ChemIDplus related topics:   Everolimus   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   XIENCE™ V Everolimus Eluting Coronary Stent System India Post-Marketing Registry

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Stent thrombosis rates as defined by Academic Research Consortium (ARC) [ Time Frame: Annually through to 5 years ] [ Designated as safety issue: Yes ]
  • Composite endpoint of cardiac death and myocardial infarction (MI) [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Composite rate of cardiac death and any MI (Q-wave and non Q-wave) [ Time Frame: at 30, 180 days and at 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and any MI (Q-wave and non Q-wave) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death , any MI (Q-wave and non Q-wave) attributed to the target vessel, and target lesion revascularization (PCI and CABG) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Death (cardiac death, vascular death, and non-cardiovascular death) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Any MI (Q-wave and non Q-wave) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: at 14, 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy [ Time Frame: at 14, 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Clinical device and procedural success [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
  • Patient health status (symptoms, physical function, and quality of life) assessed by the Seattle Angina Questionnaire [ Time Frame: at baseline, 180 days, and 1 year ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 24 hours (acute) and 30 days (sub-acute) ] [ Designated as safety issue: Yes ]
  • Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization (PCI and CABG) [ Time Frame: 30, 180 days and 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   1000
Study Start Date:   June 2008
Estimated Study Completion Date:   June 2013
Estimated Primary Completion Date:   June 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
1
The group will be monitored to evaluate XIENCE™ V EECSS continued safety and effectiveness during commercial use in real world settings.
Device: XIENCE™ V Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease

Detailed Description:

Long term surveillance studies using a drug eluting stent (DES) may help elucidate mechanisms responsible for death, myocardial infarction, and late stent thrombosis risks not observed during controlled pre-market trials.1 This study will evaluate XIENCE™ V Everolimus Eluting Coronary Stent System (EECSS) performance in the "real world" when used by a broad group of physicians at a variety of health care facilities. Consequently, this protocol will include all consecutively enrolled patients in India who consent to participate and receive the XIENCE™ V EECSS, which is expected to represent the range of clinical use during commercialization.

Adjunctive anti-platelet therapy is a critical factor in optimizing long term DES safety.2,3 Despite established guidelines that recommend 6-12 months dual antiplatelet therapy, patients with DES implants frequently stop taking their medication early. Consequently, XIENCE™ EECSS India Post-marketing Registry (XIENCE™ V India) follow-up will document patient adherence and persistence with adjunctive antiplatelet drug therapy at several time points throughout the study.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

The group will be all consecutively enrolled patients in India treated by a broad group of physicians at a variety of health care facilities, who consent to participate and receive the XIENCE™ EECSS, which is expected to represent the range of clinical use during commercialization.


Criteria

Inclusion Criteria:

  • The patient agrees to participate in this study by signing the EC approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form.

Exclusion Criteria:

  • The inability to obtain an informed consent is an exclusion criterion.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631228

Contacts
Contact: Vivian Mao     408-845-1489     vivian.mao@av.abbott.com    

Locations
India
Max Devki Devi Heart & Vascular Institute     Recruiting
      New Delhi, India, 110017
      Contact: Ashok Seth            
      Contact: , MD            
      Principal Investigator: Ashok Seth, MD            
Apollo Hospital     Recruiting
      Hyderabaad, India, 500033
      Contact: P C Rath, MD            
      Principal Investigator: P C Rath, MD            
Deenanath Mangeshkar Hospital & Research Center     Not yet recruiting
      Pune, India, 411004.
      Contact: Sheerish Sathe, MD            
      Principal Investigator: Sheerish Sathe, MD            
Poona Hospital And Research Centre     Not yet recruiting
      Pune, India, 411030
      Contact: J Hiremath, MD            
      Principal Investigator: J S Hiremath, MD            
G.B.Pant Hospital     Not yet recruiting
      New Delhi, India, 110 070
      Contact: Vijay Trehan, MD            
      Principal Investigator: Vijay Trehan, MD            
Fortis Hospital     Recruiting
      New Delhi, India, 110 070
      Contact: U Kaul, MD            
      Principal Investigator: U Kaul, MD            
Escorts Heart Institute & Research Centre     Recruiting
      New Delhi, India, 110 070
      Contact: U Kaul, MD            
      Principal Investigator: U Kaul, MD            
Escorts Heart & Superspeciality Institute Ltd.     Not yet recruiting
      Amritsar,, India
      Contact: A Chopra, MD            
      Principal Investigator: A Chopra, MD            
Holy Family Hospital     Recruiting
      Mumbai, India, 400050
      Contact: Brian Pinto, MD            
      Principal Investigator: Brian Pinto, MD            
Lisie Heart Institute,Lisie Hosp.     Recruiting
      Cochin, India
      Contact: Rony Mathew, D            
      Principal Investigator: Rony Mathew, MD            
Madras Medical Mission     Recruiting
      Chennai, India, 600 037
      Contact: Ajit Mullasari, MD            
      Principal Investigator: Ajit Mullasari, MD            
Wockhardt Hospital and Heart Institute.     Not yet recruiting
      Bangalore, India, 560052
      Contact: Ranganath Nayak, MD            
      Principal Investigator: Ranganath Nayak, MD            
SAL Hospital And Medical Institute     Recruiting
      Ahmedabad, India, 380054
      Contact: Tejas M Patel, MD            
      Principal Investigator: Tejas M Patel, MD            
India, Gujarat
Krishna Heart Institute,     Recruiting
      Ahemdabad, Gujarat, India, 380 006
      Contact: Tejas M. Patel, MD            
      Principal Investigator: Tejas M Patel            
India, Punjab
Dayanand Medical College & Hospital     Not yet recruiting
      Ludhiana, Punjab, India, 141001
      Contact: Wander, MD            
      Principal Investigator: Wander, MD            
India, Tamilnadu
Christian Medical Center (CMC)     Not yet recruiting
      Vellore, Tamilnadu, India, 632004
      Contact: Sunil T Chandy, MD            
      Principal Investigator: Sunil T Chandy, MD            

Sponsors and Collaborators
Abbott Vascular

Investigators
Principal Investigator:     Ashok Seth, MD     Max Devki Devi Heart & Vascular Institute    
Principal Investigator:     Tejas Patel, MD     Krishna Heart Institute    
  More Information

Responsible Party:   Abbott Vascular ( Vivian Mao )
Study ID Numbers:   07-378
First Received:   February 28, 2008
Last Updated:   August 11, 2008
ClinicalTrials.gov Identifier:   NCT00631228
Health Authority:   India: Central Drugs Standard Control Organization

Keywords provided by Abbott Vascular:
drug eluting stents  
stents  
Angioplasty  
coronary artery disease  
total coronary occlusion  
coronary artery restenosis
stent thrombosis
vascular disease
myocardial ischemia
coronary artery stenosis

Study placed in the following topic categories:
Everolimus
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Constriction, Pathologic
Ischemia
Arteriosclerosis
Coronary Restenosis
Coronary Stenosis
Thrombosis
Coronary Disease
Coronary Occlusion
Coronary Artery Disease

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Cardiovascular Diseases
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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