Coronary Artery DiseasePhase 4NCT01605721
Efficacy and Safety of Xience in Coronary arEry Disease aLL-comers After stENTing Using the PRIME Platform (EXCELLENT-PRIME Registry)
A Phase 4 study testing XIENCE PRIMETM everolimus-eluting coronary stent in people with Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Objectives: 1. To evaluate the safety and long-term effectiveness of coronary stenting with the XIENCE PRIMETM in a cohort of "real world" patients and lesion subsets. 2. To determine clinical device and procedural success during commercial use of XIENCE PRIMETM coronary stent Study population : Approximately… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- XIENCE PRIMETM everolimus-eluting coronary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Apr 2015
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.
- Angiographic Inclusion Criteria
- There are no angiographic inclusion criteria for this study.
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Kyung-Woo Park, MD, PhD, 82-2-2072-0244, kwparkmd@snu.ac.kr
Hyo-Soo Kim, MD, PhD
About this study
Objectives:
- To evaluate the safety and long-term effectiveness of coronary stenting with the XIENCE PRIMETM in a cohort of "real world" patients and lesion subsets.
- To determine clinical device and procedural success during commercial use of XIENCE PRIMETM coronary stent
Read more
Study population : Approximately consecutive 2000 patients treated with XIENCE PRIMETM
Study period
- Patient enrollment: 2011.05 ~ 2012.04
- End of follow-up period: 2015. 02 (3 years of follow-up)
Primary endpoint
: Target Lesion Failure (TLF) rate at 12 months
Secondary endpoint:
- In-stent \& In-segment Late Loss at 9 months
- Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late)
- Target Vessel Failure at 12 months (composite of cardiac death, MI, and TVR)
- Any death, cardiac death, MI, TLR, TVR at 30 days, 9months, 1 year, 3 years
- Composite rate of cardiac death and any MI up to 3 years
- Composite rate of all death and any MI up to 3 years
- Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years
- Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years
- Procedural success up to 1 day
- Angiographic success up to 1 day
- Conditions
- Coronary Artery Disease
- Being tested
- XIENCE PRIMETM everolimus-eluting coronary stent
- Keywords
- Everolimus, XIENCE PRIME, Drug eluting stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE PRIMETM everolimus-eluting coronary stentDevice
Active prospective registration of patients receiving the following stent
: XIENCE PRIMETM
| Study group | Role | What they receive |
|---|---|---|
| XIENCE PRIMETM everolimus-eluting coronary stent | Experimental | Not described Receives: Device: XIENCE PRIMETM everolimus-eluting coronary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF) rate at 12 months
Measured: 12 months
Secondary outcomes (9)
In-stent & In-segment Late Loss at 9 months
Measured: 9 months
Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late)
Measured: 24 hours, 30 days, up to 3 years
Any death, cardiac death, MI, TLR, TVR at 30 days, 9 months, 1 year, 3 years
Measured: 30 days, 9 months, 1 year, up to 3 years
Composite rate of cardiac death and any MI up to 3 years
Measured: up to 3 years
Composite rate of all death and any MI up to 3 years
Measured: up to 3 years
Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years
Measured: up to 3 years
Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years
Measured: up to 3 years
procedural success up to 1 day
failure : CK-MB of >3 times the upper limit of normal
Measured: 1 day
angiographic success up to 1 day
success : a minimum stenosis diameter reduction to <20% in the presence of grade 3 TIMI flow (assessed by angiography)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startMay 2011
- Primary completionApr 2013 (estimated)
- Study completionApr 2015 (estimated)
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 Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Hyo-Soo Kim, Seoul National University Hospital
- Investigators
- Hyo-Soo Kim, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605721
- Sponsor's protocol ID
- H-1101-054-347
- Status last verified
- May 2012
- First submitted
- 18 Jul 2011
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kang J, Han JK, Kang DY, Zheng C, Yang HM, Park KW, Kang HJ, Koo BK, Kim HS. SYNTAX Score and SYNTAX Score II Can Predict the Clinical Outcomes of Patients with Left Main and/or 3-Vessel Disease Undergoing Percutaneous Coronary Intervention in the Contemporary Cobalt-Chromium Everolimus-Eluting Stent Era. Korean Circ J. 2020 Jan;50(1):22-34. doi: 10.4070/kcj.2019.0097. Epub 2019 Sep 30.
PubMed 31642213
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Xience in Coronary arEry Disease aLL-comers After stENTing Using the PRIME Platform (EXCELLENT-PRIME Registry)
- ClinicalTrials.gov ID
- NCT01605721
- Acronym / sponsor ID
- H-1101-054-347
- Conditions
- Coronary Artery Disease
- Keywords
- Everolimus, XIENCE PRIME, Drug eluting stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- May 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 25 May 2012 (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.
Objectives:
- To evaluate the safety and long-term effectiveness of coronary stenting with the XIENCE PRIMETM in a cohort of "real world" patients and lesion subsets.
- To determine clinical device and procedural success during commercial use of XIENCE PRIMETM coronary stent
Study population : Approximately consecutive 2000 patients treated with XIENCE PRIMETM
Study period
- Patient enrollment: 2011.05 ~ 2012.04
- End of follow-up period: 2015. 02 (3 years of follow-up)
Primary endpoint
: Target Lesion Failure (TLF) rate at 12 months
Secondary endpoint:
- In-stent \& In-segment Late Loss at 9 months
- Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late)
- Target Vessel Failure at 12 months (composite of cardiac death, MI, and TVR)
- Any death, cardiac death, MI, TLR, TVR at 30 days, 9months, 1 year, 3 years
- Composite rate of cardiac death and any MI up to 3 years
- Composite rate of all death and any MI up to 3 years
- Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years
- Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years
- Procedural success up to 1 day
- Angiographic success up to 1 day
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XIENCE PRIMETM everolimus-eluting coronary stent | Experimental | Device: XIENCE PRIMETM everolimus-eluting coronary stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.
- Angiographic Inclusion Criteria
- There are no angiographic inclusion criteria for this study.
Key exclusion criteria (1 listed)
- There are no exclusion criteria 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 PRIMETM everolimus-eluting coronary stentActive prospective registration of patients receiving the following stent : XIENCE PRIMETM | Device | XIENCE PRIMETM everolimus-eluting coronary stent |
Primary outcome
Target Lesion Failure (TLF) rate at 12 months
Time frame: 12 months
9 secondary outcomes
In-stent & In-segment Late Loss at 9 months
Time frame: 9 months
Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late)
Time frame: 24 hours, 30 days, up to 3 years
Any death, cardiac death, MI, TLR, TVR at 30 days, 9 months, 1 year, 3 years
Time frame: 30 days, 9 months, 1 year, up to 3 years
Composite rate of cardiac death and any MI up to 3 years
Time frame: up to 3 years
Composite rate of all death and any MI up to 3 years
Time frame: up to 3 years
Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years
Time frame: up to 3 years
Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years
Time frame: up to 3 years
procedural success up to 1 day
Time frame: 1 day
angiographic success up to 1 day
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2012.
- Derived from this study: PubMed 31642213Kang J, Han JK, Kang DY, Zheng C, Yang HM, Park KW, Kang HJ, Koo BK, Kim HS. SYNTAX Score and SYNTAX Score II Can Predict the Clinical Outcomes of Patients with Left Main and/or 3-Vessel Disease Undergoing Percutaneous Coronary Intervention in the Contemporary Cobalt-Chromium Everolimus-Eluting Stent Era. Korean Circ J. 2020 Jan;50(1):22-34. doi: 10.4070/kcj.2019.0097. Epub 2019 Sep 30.
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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.
Hyo-Soo Kim, MD, PhD study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing XIENCE PRIMETM everolimus-eluting coronary stent in people with Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 25 May 2012. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung-Woo Park, MD, PhD (82-2-2072-0244, kwparkmd@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) rate at 12 months (time frame: 12 months). 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 NCT01605721, 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 25 May 2012.