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Coronary Artery DiseaseNCT02747329

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

A study testing BuMA Supreme™ stent and Xience V/Prime stent in people with Coronary Artery Disease and Stable Angina Pectoris, run by Sino Medical Sciences Technology Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
BuMA Supreme™ stent and Xience V/Prime stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteChina
Study dates
15 Jun 2016to 3 Mar 2021
Phase
Interventional
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The PLA General Hospital

    Beijing, Beijing Municipality, 100853

Other trials in China

About this study

Official title: 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）

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.

Read the 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.

Being tested
BuMA Supreme™ stent, Xience V/Prime stent
Keywords
BuMA Supreme, Xience V/Prime, OCT, neointima formation, HT Supreme
Medical subject headings
Coronary Artery Disease, Angina, Stable, Angina, Unstable, Neointima

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BuMA Supreme™ stentDevice

  • Xience V/Prime stentDevice

Study groups in NCT02747329
Study groupRoleWhat they receive
1st month OCT group implanted BuMA Supreme™ stentExperimentalThis 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.
Receives: Device: BuMA Supreme™ stent
1st month OCT group implanted Xience V/Prime stentActive comparatorThis 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.
Receives: Device: Xience V/Prime stent
2st month OCT group implanted BuMA Supreme™ stentExperimentalThis 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.
Receives: Device: BuMA Supreme™ stent
2st month OCT group implanted Xience V/Prime stentActive comparatorThis 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.
Receives: Device: Xience V/Prime stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 or 2 months

Secondary outcomes (12)

  1. Neointimal hyperplasia area/volume

    1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group

    Measured: 1 or 2 months

  2. Mean/Minimal Stent diameter/area/volume

    1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group

    Measured: 1 or 2 months

  3. Mean/Minimal Lumen diameter/area/volume

    1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group

    Measured: 1 or 2 months

  4. Mean/maximal thickness of the struts coverage

    1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group

    Measured: 1 or 2 months

  5. Incomplete strut apposition

    1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group

    Measured: 1 or 2 months

  6. Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months

    1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group

    Measured: 1 or 2 months

  7. Late Lumen Loss

    1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group

    Measured: 1 or 2 month

  8. Binary Restenosis (DS ≥50%)

    All measurements will be made of the in-stent, in-segment, proximal and distal stent margins.

    Measured: 1 or 2 months

  9. Acute success rate

    It includes the device success,lesion success and procedural success.

    Measured: up to 7 days

  10. Device-oriented Composite Endpoints and its individual components

    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.

    Measured: 1 or 2, 3, 6 months, 1 year, 2 years

  11. Stent thrombosis according to the ARC definitions

    Definite and probable stent thrombosis during acute, subacute, later and very late phase.

    Measured: 1 or 2, 3, 6 months, 1 year, 2 years

  12. bleeding events

    Measured: 1 or 2, 3, 6 months, 1 year, 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2016 (estimated)
  2. Study start15 Jun 2016
  3. Primary completion11 May 2017
  4. Study completion3 Mar 2021

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02747329
Sponsor's protocol ID
PIONEER-II OCT
Status last verified
Oct 2021
First submitted
18 Apr 2016
Last updated
13 Oct 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31174600

Questions about this trial

What is this clinical trial studying?

A study testing BuMA Supreme™ stent and Xience V/Prime stent in people with Coronary Artery Disease and Stable Angina Pectoris, run by Sino Medical Sciences Technology Inc. at 1 site in China.

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 21 inclusion and 19 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 13 Oct 2021. 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 China. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The percentage of the struts' neointimal coverage (%) at 1 or 2 months follow-up by OCT assessment. (time frame: 1 or 2 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 NCT02747329, 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 13 Oct 2021.

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