Coronary DiseaseXIENCE V IndiaNCT00631228
XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-arm Study
An observational study of Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 18 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- What is being tested?
- XIENCE V® Everolimus Eluting Coronary Stent
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 18 sitesIndia
- Study dates
- Jun 2008to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- The inability to obtain an informed consent is an exclusion criterion.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
India18 sites
Krishna Heart Institute
Ahmedabad, Gujarat, 380 006
SAL Hospital And Medical Institute
Ahmedabad, 380054
Escorts Heart & Superspeciality Institute Ltd.
Amritsar
Madras Medical Mission
Chennai, 600 037
CARE Hospital
Hyderabaad, Andhra Pradesh, 500034
Krishna Heart Institute,
Hyderabad, Andhra Pradesh, 5000003
Apollo Hospital
Hyderabad, 500033
Heart & General Hospital
Jaipur
Lisie Heart Institute,Lisie Hosp.
Kochi
Dayanand Medical College & Hospital
Ludhiana, Punjab, 141001
Holy Family Hospital
Mumbai, 400050
Escorts Heart Institute & Research Centre
New Delhi, 110 070
Fortis Hospital
New Delhi, 110 070
Max Devki Devi Heart & Vascular Institute
New Delhi, 110017
Escorts Heart Institute & Research Centre
New Delhi, 110025
Jehangir Hospital
Pune, Pune, 411001
Poona Hospital And Research Centre
Pune, 411030
Christian Medical Center (CMC)
Vellore, Tamil Nadu, 632004
About this study
Official title: XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-Arm Study
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.
Read the 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.
- Being tested
- XIENCE V® Everolimus Eluting Coronary Stent
- Keywords
- drug eluting stents, stents, Angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis
- Medical subject headings
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Vascular Diseases, Myocardial Ischemia, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE V® Everolimus Eluting Coronary StentDevice
Also called XIENCE V® Everolimus Eluting Coronary Stent System
Drug eluting stent implantation stent in the treatment of coronary artery disease
| Study group | Role | What they receive |
|---|---|---|
| 1 | The group will be monitored to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings. Receives: Device: XIENCE V® Everolimus Eluting Coronary Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent thrombosis rates as defined by Academic Research Consortium (ARC)
Measured: Annually through to 3 years
Composite endpoint of cardiac death and myocardial infarction (MI)
Measured: at 1 year
Secondary outcomes (12)
Composite rate of cardiac death and any MI (Q-wave and non Q-wave)
Measured: at 30, 180 days and at 2 and 3 years
Composite rate of all death and any MI (Q-wave and non Q-wave)
Measured: 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)
Measured: at 30, 180 days and at 2 and 3 years
Death (cardiac death, vascular death, and non-cardiovascular death)
Measured: at 30, 180 days and at 2 and 3 years
Any MI (Q-wave and non Q-wave)
Measured: at 30, 180 days and at 2 and 3 years
Major bleeding complications
Measured: at 14, 30, 180 days and at 1, 2 and 3 years
Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
Measured: at 14, 30, 180 days and at 1, 2 and 3 years
Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG)
Measured: at 30, 180 days and at 1, 2 and 3 years
Clinical device and procedural success
Measured: Acute
Patient health status (symptoms, physical function, and quality of life) assessed by the Seattle Angina Questionnaire
Measured: at baseline, 180 days, and 1 year
Stent thrombosis
Measured: 24 hours (acute) and 30 days (sub-acute)
Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization (PCI and CABG)
Measured: 30, 180 days and 1, 2 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2010
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashok Seth, MD, Principal investigator, Max Devki Devi Heart & Vascular InstituteTejas Patel, MD, Principal investigator, Krishna Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631228
- Sponsor's protocol ID
- 07-378
- Other IDs
- REFCTRI000213, 21-10-2008
- Acronym
- XIENCE V India
- Status last verified
- Aug 2012
- First submitted
- 28 Feb 2008
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25940520
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-Arm Study
- ClinicalTrials.gov ID
- NCT00631228
- Acronym / sponsor ID
- XIENCE V India / 07-378
- Keywords
- drug eluting stents, stents, Angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: XIENCE V® Everolimus Eluting Coronary StentThe group will be monitored to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The inability to obtain an informed consent is an exclusion criterion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XIENCE V® Everolimus Eluting Coronary StentAlso: XIENCE V® Everolimus Eluting Coronary Stent SystemDrug eluting stent implantation stent in the treatment of coronary artery disease | Device | 1 |
Primary outcome
Stent thrombosis rates as defined by Academic Research Consortium (ARC)
Time frame: Annually through to 3 years
Composite endpoint of cardiac death and myocardial infarction (MI)
Time frame: at 1 year
12 secondary outcomes
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
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
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
Death (cardiac death, vascular death, and non-cardiovascular death)
Time frame: at 30, 180 days and at 2 and 3 years
Any MI (Q-wave and non Q-wave)
Time frame: at 30, 180 days and at 2 and 3 years
Major bleeding complications
Time frame: at 14, 30, 180 days and at 1, 2 and 3 years
Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
Time frame: at 14, 30, 180 days and at 1, 2 and 3 years
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
Clinical device and procedural success
Time frame: Acute
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
Stent thrombosis
Time frame: 24 hours (acute) and 30 days (sub-acute)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
- Derived from this study: PubMed 25940520Genereux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashok Seth, MD principal investigator
Max Devki Devi Heart & Vascular Institute
Tejas Patel, MD principal investigator
Krishna Heart Institute
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 18 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent thrombosis rates as defined by Academic Research Consortium (ARC) (time frame: Annually through to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00631228, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2012.