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

NCT00631228 | Completed DMC

• 2 other identifiers: 07-378REFCTRI000213, 21-10-2008
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Keywords

drug eluting stents; stents; Angioplasty; coronary artery disease; total coronary occlusion; coronary artery restenosis; stent thrombosis; vascular disease; myocardial ischemia; coronary artery stenosis

Outcome Measures

Primary Outcomes (2)

• Stent thrombosis rates as defined by Academic Research Consortium (ARC)

  Annually through to 3 years

• Composite endpoint of cardiac death and myocardial infarction (MI)

  at 1 year

Secondary Outcomes (12)

• Composite rate of cardiac death and any MI (Q-wave and non Q-wave)

  at 30, 180 days and at 2 and 3 years

• Composite rate of all death and any MI (Q-wave and non Q-wave)

  at 30, 180 days and at 2 and 3 years

• 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)

  at 30, 180 days and at 2 and 3 years

• Death (cardiac death, vascular death, and non-cardiovascular death)

  at 30, 180 days and at 2 and 3 years

• Any MI (Q-wave and non Q-wave)

  at 30, 180 days and at 2 and 3 years

Study Arms (1)

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

Interventions

XIENCE V® Everolimus Eluting Coronary Stent DEVICE

Drug eluting stent implantation stent in the treatment of coronary artery disease

Also known as: XIENCE V® Everolimus Eluting Coronary Stent System

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (18)

CARE Hospital

Hyderabaad, Andhra Pradesh, 500034, India

Location

Krishna Heart Institute,

Hyderabad, Andhra Pradesh, 5000003, India

Location

Krishna Heart Institute

Ahmedabad, Gujarat, 380 006, India

Location

Jehangir Hospital

Pune, Pune, 411001, India

Location

Dayanand Medical College & Hospital

Ludhiana, Punjab, 141001, India

Location

Christian Medical Center (CMC)

Vellore, Tamil Nadu, 632004, India

Location

SAL Hospital And Medical Institute

Ahmedabad, 380054, India

Location

Escorts Heart & Superspeciality Institute Ltd.

Amritsar, India

Location

Madras Medical Mission

Chennai, 600 037, India

Location

Apollo Hospital

Hyderabad, 500033, India

Location

Heart & General Hospital

Jaipur, India

Location

Lisie Heart Institute,Lisie Hosp.

Kochi, India

Location

Holy Family Hospital

Mumbai, 400050, India

Location

Escorts Heart Institute & Research Centre

New Delhi, 110 070, India

Location

Fortis Hospital

New Delhi, 110 070, India

Location

Max Devki Devi Heart & Vascular Institute

New Delhi, 110017, India

Location

Escorts Heart Institute & Research Centre

New Delhi, 110025, India

Location

Poona Hospital And Research Centre

Pune, 411030, India

Location

Related Publications (1)

• Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.

  PMID: 25940520 DERIVED

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Vascular Diseases; Myocardial Ischemia; Coronary Stenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Ashok Seth, MD

  Max Devki Devi Heart & Vascular Institute

  PRINCIPAL INVESTIGATOR

• Tejas Patel, MD

  Krishna Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: August 1, 2012
• Last Updated: August 14, 2012

Record last verified: 2012-08

Locations

IN (18)