- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02747329
A Comparative Evaluation of the Extent of Neointima Formation at 1 Month and 2 Months After Implantation Using OCT
A Prospective, Multicenter, Randomized Comparative Evaluation of BuMA Supreme Stent and of Xience Stent in Terms of the Extent of Neointimal Formation at 1 Month and 2 Months Via OCT After Implantation in High Bleeding Risk CAD Patients(PIONEER-II OCT Study)
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a prospective, multicenter, randomized, non-inferiority study, which will enroll a total of 80 subjects from approximately 8 centers. All subjects will be firstly randomly assigned to 1st month OCT (40 pts) or 2nd month OCT group(40 pts). Then both two groups will be randomly assigned to undergoing implantation of BuMA Supreme™ stent (20 pts) or Xience V/Prime stent (20 pts). If non-inferiority was met, superiority test will be planned.
All of the patients be followed up to 2 years. The follow-up visits will be conducted at 1 or 2 months (including QCA/OCT investigation), 3 months, 6 months, 1 and 2 years post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing
-
BeiJing, Beijing, China, 100853
- The PLA General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 to 85 years.
- Evidence of myocardial ischemia without raised troponin (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study).
Any one or more situation listed below can be considered the patient at high bleeding risk by the doctor:
- Adjunctive oral anticoagulation treatment planned to continue after PCI;
- Baseline Hb ≥11 g/dl (or anemia requiring TF during the prior 4 weeks);
- Any prior intra-cerebral bleed at any time;
- Any stroke during the past year;
- Hospital admission for bleeding during the prior 12 months;
- Non-skin cancer diagnosed or treated ≤ 3 years;
- Planned daily NSAID (other than aspirin) or steroids for ≥ 30 days after PCI;
- Planned major surgery (within 1 year);
- Renal failure (calculated creatinine clearance ≥ 40 ml/min);
- Thrombocytopenia (≥ 100,000/mm3);
- Severe chronic liver disease (variceal hemorrhage, ascites, hepatic encephalopathy or jaundice);
Expected non-compliance to prolonged DAPT for other medical (nonfinancial)reasons ;
- NSAID, Non-steroidal anti-inflammatory drug; TF, blood transfusion.
- The patient has a planned intervention of up to two de novo lesions, in different epicardial vessels.
- Lesion(s) must have a visually estimated diameter stenosis of ≥70% and <100%.
- Reference Vessel Diameter (RVD) must be between 2.5- 4.0mm, and the vessel length must be no more than 40 mm.
- Written informed consent.
- The patient and the patient's physician agree to the follow-up visits including angiographic follow-up and OCT controls at 1 or 2 month.
Exclusion Criteria:
- Evidence of ongoing acute myocardial infarction in ECG prior to procedure.
- Left ventricular ejection fraction (LVEF) <30%.
- The patient is a recipient of a heart transplant.
- Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel and ticlopidine), sirolimus or stainless steel, cobalt metal or sensitivity to contrast media, which cannot be adequately pre-medicated.
- Other medical illness (e.g. skin cancer diagnosed or treated > 3 years, neurological deficiency) or known history of substance abuse (alcohol etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy.
- Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
- Chronic total occlusion(TIMI 0), left main lesion, intervention-required three-vessel lesions, branch vessel diameter ≥ 2.5mm and bypass lesion
- Patients expected not to comply with 1 month DAPT;
- Compliance with long-term single anti-platelet therapy unlikely;
- Active bleeding at the time of inclusion;
- Patients requiring a planned staged PCI procedure more than one week after theindex procedure;
- Procedure planned to require non-study stents, or stand alone POBA or stand-alone atherectomy;
- Reference vessel diameter <2.25 - >4.0mm, vessel length >40mm;
- Cardiogenic shock;
- Participation in another clinical trial (12 months after index procedure).
- Those who is not suitable to attend this trial after the evaluation by the doctor.
OCT exclusion criteria
- Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
- Total occlusion or thrombolysis in myocardial infarction(TIMI) flow 0, prior to wire crossing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1st month OCT group implanted BuMA Supreme™ stent
This group contains 20 subjects.
All subjects in this group will undergoing implantation of BuMA Supreme™ stent.
The Primary Endpoint of this group is 1st month QCA and OCT assessment.
|
|
ACTIVE_COMPARATOR: 1st month OCT group implanted Xience V/Prime stent
This group contains 20 subjects.
All subjects in this group will undergoing implantation of Xience V/Prime stent.
The Primary Endpoint of this group is 1st month QCA and OCT assessment.
|
|
EXPERIMENTAL: 2st month OCT group implanted BuMA Supreme™ stent
This group contains 20 subjects.
All subjects in this group will undergoing implantation of BuMA Supreme™ stent.
The Primary Endpoint of this group is 2st month QCA and OCT assessment.
|
|
ACTIVE_COMPARATOR: 2st month OCT group implanted Xience V/Prime stent
This group contains 20 subjects.
All subjects in this group will undergoing implantation of Xience V/Prime stent.
The Primary Endpoint of this group is 2st month QCA and OCT assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of the struts' neointimal coverage (%) at 1 or 2 months follow-up by OCT assessment.
Time Frame: 1 or 2 months
|
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
|
1 or 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neointimal hyperplasia area/volume
Time Frame: 1 or 2 months
|
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
|
1 or 2 months
|
Mean/Minimal Stent diameter/area/volume
Time Frame: 1 or 2 months
|
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
|
1 or 2 months
|
Mean/Minimal Lumen diameter/area/volume
Time Frame: 1 or 2 months
|
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
|
1 or 2 months
|
Mean/maximal thickness of the struts coverage
Time Frame: 1 or 2 months
|
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
|
1 or 2 months
|
Incomplete strut apposition
Time Frame: 1 or 2 months
|
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
|
1 or 2 months
|
Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months
Time Frame: 1 or 2 months
|
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
|
1 or 2 months
|
Late Lumen Loss
Time Frame: 1 or 2 month
|
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
|
1 or 2 month
|
Binary Restenosis (DS ≥50%)
Time Frame: 1 or 2 months
|
All measurements will be made of the in-stent, in-segment, proximal and distal stent margins.
|
1 or 2 months
|
Acute success rate
Time Frame: up to 7 days
|
It includes the device success,lesion success and procedural success.
|
up to 7 days
|
Device-oriented Composite Endpoints and its individual components
Time Frame: 1 or 2, 3, 6 months, 1 year, 2 years
|
Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, Myocardial Infarction(MI) not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
|
1 or 2, 3, 6 months, 1 year, 2 years
|
Stent thrombosis according to the ARC definitions
Time Frame: 1 or 2, 3, 6 months, 1 year, 2 years
|
Definite and probable stent thrombosis during acute, subacute, later and very late phase.
|
1 or 2, 3, 6 months, 1 year, 2 years
|
bleeding events
Time Frame: 1 or 2, 3, 6 months, 1 year, 2 years
|
1 or 2, 3, 6 months, 1 year, 2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yundai Y Chen, Ph.D., The PLA General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIONEER-II OCT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on BuMA Supreme™ stent
-
Sino Medical Sciences Technology Inc.Active, not recruitingCoronary Artery DiseaseChina
-
Sino Medical Sciences Technology Inc.CompletedCoronary Artery DiseaseNetherlands, Belgium, Spain, Portugal
-
Sino Medical Sciences Technology Inc.Active, not recruitingCoronary Artery DiseaseChina
-
Sino Medical Sciences Technology Inc.Nova Vascular LLCActive, not recruitingCoronary Artery DiseaseSpain, United States, Netherlands, Belgium, Switzerland, United Kingdom, Canada, Japan
-
Sino Medical Sciences Technology Inc.CompletedCoronary Heart Disease | Stable Angina Pectoris | Unstable Angina Pectoris | Silent Myocardial IschemiaChina
-
Tufts UniversityKavo Kerr GroupCompletedDental CariesUnited States
-
Ondokuz Mayıs UniversityRecruiting
-
Lombard MedicalSuspendedAbdominal Aortic AneurysmsUnited Kingdom, Germany, New Zealand, Spain, Czechia, Italy
-
Lifetech Scientific (Shenzhen) Co., Ltd.RecruitingAbdominal Aortic AneurysmTurkey, Bulgaria, Greece
-
Lombard MedicalCompletedAbdominal Aortic AneurysmsUnited States