AngioplastyXP China SASNCT01894152
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
An observational study of Angioplasty and Cardiovascular Disease, run by Abbott Medical Devices at 1 site in United States.
Trial summary
Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioplasty, Cardiovascular Disease, Coronary Artery Disease
- What is being tested?
- XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
- Type of treatment
- Medical device
- How many people
- 2,002 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 9 Oct 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in realworld settings in China.
Who may be able to join
- The patient must be at least 18 years of age at the time of signing the informed consent.
- The patient or his/her legally-authorized representative signs the European Commission (EC)-approved Informed Consent Form (ICF).
- Only XIENCE PRIME stent(s) is (are) implanted during the index procedure.
Who cannot join
- No other exclusion criteria are specified for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Continued Safety and Effectiveness of the XIENCE PRIME EECSS in a Cohort of Real-world Patients Receiving the XIENCE PRIME EECSS During Commercial Use.
Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.
This prospective, observational, open-label, multi-center, single-arm, post-approval study is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in real-world settings in China.
This study has no primary outcome measure. All observations are of equal weight.
- Conditions
- Angioplasty, Cardiovascular Disease, Coronary Artery Disease, Coronary Heart Disease, Coronary Restenosis, Myocardial Infarction
- Being tested
- XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
- Keywords
- XIENCE PRIME EECSS, XIENCE V EECSS, XIENCE PRIME, SPIRIT PRIME, XIENCE PRIME SV (Small Vessel), XIENCE PRIME LL (Long Lesion), Coronary Artery Disease, Coronary Heart Disease, Cardiovascular Disease, Myocardial Infarction, Stent Thrombosis
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Coronary Restenosis, Myocardial Infarction, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)Device
Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
| Study group | Role | What they receive |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) Receives: Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint
Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Myocardial Infarction (MI):
- Q wave MI: Development of new, pathological Q wave on the ECG.
- Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Measured: ≤ 7 days after index procedure (Hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJul 2013
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AngioplastyStudies 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
- 2,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, MB, MSc, MD, Principal investigator, Fudan UniversityFang Chen, MD, Principal investigator, Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894152
- Sponsor's protocol ID
- 12-396
- Acronym
- XP China SAS
- Status last verified
- May 2020
- First submitted
- 1 Jul 2013
- Last updated
- 26 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Continued Safety and Effectiveness of the XIENCE PRIME EECSS in a Cohort of Real-world Patients Receiving the XIENCE PRIME EECSS During Commercial Use.
- ClinicalTrials.gov ID
- NCT01894152
- Acronym / sponsor ID
- XP China SAS / 12-396
- Conditions
- Angioplasty, Cardiovascular Disease, Coronary Artery Disease, Coronary Heart Disease, Coronary Restenosis, Myocardial Infarction
- Keywords
- XIENCE PRIME EECSS, XIENCE V EECSS, XIENCE PRIME, SPIRIT PRIME, XIENCE PRIME SV (Small Vessel), XIENCE PRIME LL (Long Lesion), Coronary Artery Disease, Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,002 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Posted 1 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.
This prospective, observational, open-label, multi-center, single-arm, post-approval study is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in real-world settings in China.
This study has no primary outcome measure. All observations are of equal weight.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | – | Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in realworld settings in China.
Key inclusion criteria (3 listed)
- The patient must be at least 18 years of age at the time of signing the informed consent.
- The patient or his/her legally-authorized representative signs the European Commission (EC)-approved Informed Consent Form (ICF).
- Only XIENCE PRIME stent(s) is (are) implanted during the index procedure.
Key exclusion criteria (1 listed)
- No other exclusion criteria are specified for this study.
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 PRIME Everolimus Eluting Coronary Stent System (EECSS)Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Device | XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) |
Primary outcome
Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint
Time frame: ≤ 7 days after index procedure (Hospitalization)
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Junbo Ge, MB, MSc, MD principal investigator
Fudan University
Fang Chen, MD principal investigator
Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angioplasty and Cardiovascular Disease, run by Abbott Medical Devices at 1 site in United States.
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 3 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 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 1 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint (time frame: ≤ 7 days after index procedure (Hospitalization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2020.