A Comparative Evaluation of the Extent of Neointima Formation at 1 Month and 2 Months After Implantation Using OCT
NCT ID: NCT02747329
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
82 participants
INTERVENTIONAL
2016-06-15
2021-03-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
BuMA Supreme™ stent
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.
Xience V/Prime stent
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.
BuMA Supreme™ stent
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.
Xience V/Prime stent
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BuMA Supreme™ stent
Xience V/Prime stent
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Evidence of myocardial ischemia without raised troponin (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study).
3. 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.
4. The patient has a planned intervention of up to two de novo lesions, in different epicardial vessels.
5. Lesion(s) must have a visually estimated diameter stenosis of ≥70% and \<100%.
6. Reference Vessel Diameter (RVD) must be between 2.5- 4.0mm, and the vessel length must be no more than 40 mm.
7. Written informed consent.
8. 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
2. Left ventricular ejection fraction (LVEF) \<30%.
3. The patient is a recipient of a heart transplant.
4. 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.
5. 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.
6. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
7. Chronic total occlusion(TIMI 0), left main lesion, intervention-required three-vessel lesions, branch vessel diameter ≥ 2.5mm and bypass lesion
8. Patients expected not to comply with 1 month DAPT；
9. Compliance with long-term single anti-platelet therapy unlikely；
10. Active bleeding at the time of inclusion；
11. Patients requiring a planned staged PCI procedure more than one week after theindex procedure；
12. Procedure planned to require non-study stents, or stand alone POBA or stand-alone atherectomy；
13. Reference vessel diameter \<2.25 - \>4.0mm, vessel length \>40mm；
14. Cardiogenic shock；
15. Participation in another clinical trial (12 months after index procedure).
16. Those who is not suitable to attend this trial after the evaluation by the doctor.
* 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.
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sino Medical Sciences Technology Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yundai Y Chen, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
the PLA General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The PLA General Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Li B, Jin QH, Chen YD, Wang CQ, Shi B, Su X, Fu GS, Wu YQ, Zhou XC, Yuan ZY. A prospective, multicenter, randomized OCT study of early neointimal condition at first and second months after BuMA Supreme stent versus XIENCE stent implantation in high-bleeding-risk coronary artery disease patients: study protocol for a randomized controlled trial. Trials. 2019 Jun 7;20(1):335. doi: 10.1186/s13063-019-3361-0.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PIONEER-II OCT
Identifier Type: -
Identifier Source: org_study_id