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XIENCE V® Everolimus Eluting Coronary Stent System India Post-Marketing Registry (XIENCE V India)
This study is ongoing, but not recruiting participants.
First Received: February 28, 2008   Last Updated: April 29, 2009   History of Changes
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
Drug Information available for: 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. 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. Despite established guidelines that recommend 6-12 months dual antiplatelet therapy, patients with DES implants frequently stop taking their medication early. Consequently, XIENCE V® 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 V® 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

Locations
India
Max Devki Devi Heart & Vascular Institute
New Delhi, India, 110017
Apollo Hospital
Hyderabaad, India, 500033
Poona Hospital And Research Centre
Pune, India, 411030
Escorts Heart & Superspeciality Institute Ltd.
Amritsar, India
Lisie Heart Institute,Lisie Hosp.
Cochin, India
Escorts Heart Institute & Research Centre
New Delhi, India, 110 070
Holy Family Hospital
Mumbai, India, 400050
Fortis Hospital
New Delhi, India, 110 070
Madras Medical Mission
Chennai, India, 600 037
SAL Hospital And Medical Institute
Ahmedabad, India, 380054
Heart & General Hospital
Jaipur, India
Jehangir Hospital
Pune, India, 411001
India, Andhra Pradesh
CARE Hospital
Hyderabaad, Andhra Pradesh, India, 500034
India, Gujarat
Krishna Heart Institute,
Ahemdabad, Gujarat, India, 380 006
India, Punjab
Dayanand Medical College & Hospital
Ludhiana, Punjab, India, 141001
India, Tamilnadu
Christian Medical Center (CMC)
Vellore, Tamilnadu, India, 632004
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

No publications provided

Responsible Party: Abbott Vascular ( Vivian Mao )
Study ID Numbers: 07-378
Study First Received: February 28, 2008
Last Updated: April 29, 2009
ClinicalTrials.gov Identifier: NCT00631228     History of Changes
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
Immunologic Factors
Myocardial Ischemia
Vascular Diseases
Constriction, Pathologic
Ischemia
Arteriosclerosis
Immunosuppressive Agents
Coronary Restenosis
Coronary Stenosis
Thrombosis
Coronary Disease
Coronary Occlusion
Coronary Artery Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Everolimus
Heart Diseases
Immunologic Factors
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Arteriosclerosis
Coronary Restenosis
Coronary Stenosis
Immunosuppressive Agents
Pharmacologic Actions
Coronary Disease
Cardiovascular Diseases
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009