XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-arm Study (XIENCE V India)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00631228
First received: February 28, 2008
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

XIENCE V® India is a prospective, open-label, multi-center, observational, single-arm study 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 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-Arm Study

Resource links provided by NLM:


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 3 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 and 3 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 2 and 3 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 2 and 3 years ] [ Designated as safety issue: Yes ]
  • Death (cardiac death, vascular death, and non-cardiovascular death) [ Time Frame: at 30, 180 days and at 2 and 3 years ] [ Designated as safety issue: Yes ]
  • Any MI (Q-wave and non Q-wave) [ Time Frame: at 30, 180 days and at 2 and 3 years ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: at 14, 30, 180 days and at 1, 2 and 3 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 and 3 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 and 3 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 and 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 1000
Study Start Date: June 2008
Study Completion Date: August 2012
Primary Completion Date: April 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
Other Name: XIENCE V® Everolimus Eluting Coronary Stent System

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 Single-Arm Study (XIENCE V® India) follow-up will document patient adherence and persistence with adjunctive antiplatelet drug therapy at several time points throughout the study.

The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.

The post approval XIENCE V India study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.

Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the XIENCE V India study, from 5 years to after completion of the three year follow-up.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
India
CARE Hospital
Hyderabaad, Andhra Pradesh, India, 500034
Krishna Heart Institute,
Hyderabad, Andhra Pradesh, India, 5000003
Krishna Heart Institute
Ahmedabad, Gujarat, India, 380 006
Dayanand Medical College & Hospital
Ludhiana, Punjab, India, 141001
Christian Medical Center (CMC)
Vellore, Tamilnadu, India, 632004
SAL Hospital And Medical Institute
Ahmedabad, India, 380054
Escorts Heart & Superspeciality Institute Ltd.
Amritsar, India
Madras Medical Mission
Chennai, India, 600 037
Lisie Heart Institute,Lisie Hosp.
Cochin, India
Apollo Hospital
Hyderabad, India, 500033
Heart & General Hospital
Jaipur, India
Holy Family Hospital
Mumbai, India, 400050
Escorts Heart Institute & Research Centre
New Delhi, India, 110025
Fortis Hospital
New Delhi, India, 110 070
Escorts Heart Institute & Research Centre
New Delhi, India, 110 070
Max Devki Devi Heart & Vascular Institute
New Delhi, India, 110017
Jehangir Hospital
Pune, India, 411001
Poona Hospital And Research Centre
Pune, India, 411030
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
ClinicalTrials.gov Identifier: NCT00631228     History of Changes
Other Study ID Numbers: 07-378, REFCTRI000213, 21-10-2008
Study First Received: February 28, 2008
Last Updated: August 13, 2012
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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on July 31, 2014