Clinical trial NCT00631228: XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-arm Study
Official title: XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-Arm Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Stent thrombosis rates as defined by Academic Research Consortium (ARC)
timeFrame: Annually through to 3 years
measure: Composite endpoint of cardiac death and myocardial infarction (MI)
timeFrame: at 1 year
Secondary outcomes:
measure: Composite rate of cardiac death and any MI (Q-wave and non Q-wave)
timeFrame: at 30, 180 days and at 2 and 3 years
measure: Composite rate of all death and any MI (Q-wave and non Q-wave)
timeFrame: at 30, 180 days and at 2 and 3 years
measure: 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)
timeFrame: at 30, 180 days and at 2 and 3 years
measure: Death (cardiac death, vascular death, and non-cardiovascular death)
timeFrame: at 30, 180 days and at 2 and 3 years
measure: Any MI (Q-wave and non Q-wave)
timeFrame: at 30, 180 days and at 2 and 3 years
measure: Major bleeding complications
timeFrame: at 14, 30, 180 days and at 1, 2 and 3 years
measure: Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
timeFrame: at 14, 30, 180 days and at 1, 2 and 3 years
measure: Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG)
timeFrame: at 30, 180 days and at 1, 2 and 3 years
measure: Clinical device and procedural success
timeFrame: Acute
measure: Patient health status (symptoms, physical function, and quality of life) assessed by the Seattle Angina Questionnaire
timeFrame: at baseline, 180 days, and 1 year
measure: Stent thrombosis
timeFrame: 24 hours (acute) and 30 days (sub-acute)
measure: Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization (PCI and CABG)
timeFrame: 30, 180 days and 1, 2 and 3 years
Other outcomes:
Locations:
city: Hyderabaad
country: India
facility: CARE Hospital
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Krishna Heart Institute,
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Krishna Heart Institute
state: Gujarat
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital
state: Punjab
city: Vellore
country: India
facility: Christian Medical Center (CMC)
state: Tamilnadu
city: Ahmedabad
country: India
facility: SAL Hospital And Medical Institute
city: Amritsar
country: India
facility: Escorts Heart & Superspeciality Institute Ltd.
city: Chennai
country: India
facility: Madras Medical Mission
city: Cochin
country: India
facility: Lisie Heart Institute,Lisie Hosp.
city: Hyderabad
country: India
facility: Apollo Hospital
city: Jaipur
country: India
facility: Heart & General Hospital
city: Mumbai
country: India
facility: Holy Family Hospital
city: New Delhi
country: India
facility: Escorts Heart Institute & Research Centre
city: New Delhi
country: India
facility: Fortis Hospital
city: New Delhi
country: India
facility: Max Devki Devi Heart & Vascular Institute
city: New Delhi
country: India
facility: Escorts Heart Institute & Research Centre
city: Pune
country: India
facility: Jehangir Hospital
city: Pune
country: India
facility: Poona Hospital And Research Centre
Study officials:
affiliation: Max Devki Devi Heart & Vascular Institute
name: Ashok Seth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Krishna Heart Institute
name: Tejas Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.