AtherosclerosisNCT02230254
PE PREMIER CHINA CLINICAL TRIAL
A study testing Percutaneous coronary intervention PROMUS PREMIER in people with Atherosclerosis, run by Boston Scientific Corporation.
Trial summary
PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Percutaneous coronary intervention PROMUS PREMIER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 9 Apr 2014to 31 Jul 2015
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Inclusion (CI) Criteria
- CI1. Subject must be at least 18 -75 years of age
- CI2. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
- CI3. Subject is eligible for percutaneous coronary intervention (PCI)
- CI4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
- CI5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
Show all 14Show fewer
- CI6. Subject is willing to comply with all protocol-required follow-up evaluation
- CI7. Subject has a left ventricular ejection fraction (LVEF) >30% as measured within 60 days prior to enrollment
- Angiographic Inclusion (AI) Criteria (visual estimate)
- AI1. Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm
- AI2. Target lesion(s) length must be ≤34 mm ( Target lesion(s) length must be ≤28 mm for reference vessel diameter (RVD) = 2.25 mm Target lesion(s)) (by visual estimate)
- AI3. Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following (stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress test or imaging stress test, or elevated biomarkers) prior to procedure
- AI4. Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
- AI5. The first lesion treated must be successfully pre-dilated/pretreated Note: Successful pre-dilatation/pretreatment refers to dilatation with a balloon catheter of appropriate length and diameter, or pretreatment with/or rotational coronary atherectomy, or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.
Who cannot join
- Clinical Exclusion (CE) Criteria
- CE1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with Acute MI (include STEMI and Non- STEMI ) within 1 week
- CE2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
- CE3. Subject has received an organ transplant or is on a waiting list for an organ transplant
- CE4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
- CE5. Planned PCI (including staged procedures) or CABG after the index procedure
Show all 44Show fewer
- CE6. Subject previously treated at any time with intravascular brachytherapy
- CE7. Subject has a known allergy to contrast (that cannot be adequately pre-medicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, Clopidogrel , or aspirin)
- CE8. Subject has one of the following (as assessed prior to the index procedure):
- Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 12 months
- Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
- Planned procedure that may cause non-compliance with the protocol or confound data interpretation
- CE9. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome
- CE10. Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant.
- CE11. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
- CE12. Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
- CE13. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
- CE14. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
- CE15. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
- CE16. Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the time of the index procedure
- CE17. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
- CE18. Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
- CE19. Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
- CE20. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
- CE21.Target vessel has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure
- Angiographic Exclusion (AE) Criteria (visual estimate)
- AE1. Planned treatment of more than 3 lesions.
- AE2. Planned treatment of lesions in more than 2 major epicardial vessels
- AE3. Planned treatment of a single lesion with more than 1 stent
- AE4. Subject has 2 target lesions in the same vessel that are separated by less than 20 mm (by visual estimate)
- AE5. Target lesion(s) is located in the left main
- AE6. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate.
- AE7. Target lesion(s) is located within a saphenous vein graft or an arterial graft
- AE8. Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
- AE9. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
- AE10. Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
- AE11. Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
- AE12. Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
- AE13. Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
- AE14. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
- AE15. Excessive tortuosity proximal to or within the lesion
- AE16. Excessive angulation proximal to or within the lesion
- AE17. Target lesion and/or the target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
- AE18. Involves a side branch ≥2.0 mm in diameter by visual estimate or a side branch <2.0 mm in diameter by visual estimate which requires treatment
About this study
Official title: PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
Read the detailed description
To evaluate clinical and peri-procedural angiographic outcomes for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate)
- Conditions
- Atherosclerosis
- Being tested
- Percutaneous coronary intervention PROMUS PREMIER
- Keywords
- Coronary Artery Disease
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention PROMUS PREMIERDevice
PROMUS PREMIER
| Study group | Role | What they receive |
|---|---|---|
| PROMUS POREMIER stent | Experimental | Single-arm treatment group receiving interventional PROMUS PRIMIER study stent Receives: Device: Percutaneous coronary intervention PROMUS PREMIER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success Rate
Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcomes (17)
Target Lesion Revascularization (TLR) Rate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Target Lesion Failure (TLF) Rate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Target Vessel Revascularization (TVR) Rate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6month and 12months
Target Vessel Failure (TVF) Rate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Cardiac Death Rate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Non-cardiac Death Rate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
All Death Rate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Cardiac Death or MI Rate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
All Death or MI Rate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
All Death/MI/TVR Rate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Clinical Procedural Success Rate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
In-stent and In-segment Percent Diameter Stenosis (%DS)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
In-stent and In-segment Minimum Lumen Diameter (MLD)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Acute Gain
as measured by angiographic core lab, change from baseline for target lesions
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Longitudinal Stent Deformation (LSD) Rate
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study start9 Apr 2014
- Primary completion22 Jun 2014
- Study completion31 Jul 2015
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 AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian'an Wang, Doctor, Principal investigator, 2nd affiliated hospital of Zhejiang University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230254
- Sponsor's protocol ID
- S2323
- Status last verified
- Feb 2022
- First submitted
- 20 Aug 2014
- Last updated
- 12 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
- ClinicalTrials.gov ID
- NCT02230254
- Acronym / sponsor ID
- S2323
- Conditions
- Atherosclerosis
- Keywords
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2014 (actual)
- Primary completion
- 22 Jun 2014 (actual)
- Study completion
- 31 Jul 2015 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Posted 12 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
Detailed description
To evaluate clinical and peri-procedural angiographic outcomes for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROMUS POREMIER stent | Experimental | Device: Percutaneous coronary intervention PROMUS PREMIERSingle-arm treatment group receiving interventional PROMUS PRIMIER study stent |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Clinical Inclusion (CI) Criteria
- CI1. Subject must be at least 18 -75 years of age
- CI2. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
- CI3. Subject is eligible for percutaneous coronary intervention (PCI)
- CI4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
Key exclusion criteria (44 listed)
- Clinical Exclusion (CE) Criteria
- CE1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with Acute MI (include STEMI and Non- STEMI ) within 1 week
- CE2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
- CE3. Subject has received an organ transplant or is on a waiting list for an organ transplant
- CE4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
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 |
|---|---|---|
| Percutaneous coronary intervention PROMUS PREMIERPROMUS PREMIER | Device | PROMUS POREMIER stent |
Primary outcome
Technical Success Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician
17 secondary outcomes
Target Lesion Revascularization (TLR) Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Target Lesion Failure (TLF) Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Target Vessel Revascularization (TVR) Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6month and 12months
Target Vessel Failure (TVF) Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Cardiac Death Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Non-cardiac Death Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
All Death Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Cardiac Death or MI Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
All Death or MI Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
All Death/MI/TVR Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Clinical Procedural Success Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
In-stent and In-segment Percent Diameter Stenosis (%DS)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
In-stent and In-segment Minimum Lumen Diameter (MLD)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Acute Gain
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Longitudinal Stent Deformation (LSD) Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- 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.
Jian'an Wang, Doctor principal investigator
2nd affiliated hospital of Zhejiang University College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention PROMUS PREMIER in people with Atherosclerosis, run by Boston Scientific Corporation.
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 14 inclusion and 44 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 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 12 May 2022). 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?
Technical Success Rate (time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day). 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 12 May 2022.