A Comparative Evaluation of the Extent of Neointima Formation at 1 Month and 2 Months After Implantation Using OCT

NCT02747329 | Completed DMC

• 1 other identifier: PIONEER-II OCT
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is a comparative evaluation of BuMA Supreme™ stent and of Xience V/Prime stent in terms of the extent of neointima formation at 1 or 2 months after implanting in relatively high bleeding risk patients with coronary artery disease using OCT.

Conditions

Coronary Artery Disease; Stable Angina Pectoris; Unstable Angina Pectoris

Keywords

BuMA Supreme; Xience V/Prime; OCT; neointima formation; HT Supreme

Outcome Measures

Primary Outcomes (1)

• The percentage of the struts' neointimal coverage (%) at 1 or 2 months follow-up by OCT assessment.

  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 Outcomes (12)

• Neointimal hyperplasia area/volume

  1 or 2 months

• Mean/Minimal Stent diameter/area/volume

  1 or 2 months

• Mean/Minimal Lumen diameter/area/volume

  1 or 2 months

• Mean/maximal thickness of the struts coverage

  1 or 2 months

• Incomplete strut apposition

  1 or 2 months

Study Arms (4)

1st month OCT group implanted BuMA Supreme™ stent

EXPERIMENTAL

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.

Device: BuMA Supreme™ stent

1st month OCT group implanted Xience V/Prime stent

ACTIVE COMPARATOR

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.

Device: Xience V/Prime stent

2st month OCT group implanted BuMA Supreme™ stent

EXPERIMENTAL

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.

Device: BuMA Supreme™ stent

2st month OCT group implanted Xience V/Prime stent

ACTIVE COMPARATOR

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.

Device: Xience V/Prime stent

Interventions

BuMA Supreme™ stent DEVICE

1st month OCT group implanted BuMA Supreme™ stent; 2st month OCT group implanted BuMA Supreme™ stent

Xience V/Prime stent DEVICE

1st month OCT group implanted Xience V/Prime stent; 2st month OCT group implanted Xience V/Prime stent

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ；

You may not qualify if:

• 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；
• 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.

Sponsors & Collaborators

• Sino Medical Sciences Technology Inc.: lead

Study Sites (1)

The PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

• 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.

  PMID: 31174600 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Angina, Unstable; Neointima

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Yundai Y Chen, Ph.D.

  the PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 21, 2016
• Study Start: June 15, 2016
• Primary Completion: May 11, 2017
• Study Completion: March 3, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

CN (1)