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

Coronary Artery Disease Clinical Trial

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）

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747329
• Other study ID #: PIONEER-II OCT
• Status: Completed
• Phase: N/A
• Start date: June 15, 2016
• Est. completion date: March 3, 2021

Study information

• Verified date: October 2021
• Source: Sino Medical Sciences Technology Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 3, 2021
• Est. primary completion date: May 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 18 to 85 years.

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:

1. Evidence of ongoing acute myocardial infarction in ECG prior to procedure.

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.

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Stable Angina Pectoris
• Unstable Angina Pectoris

Intervention

Device:
• BuMA Supreme™ stent

• Xience V/Prime stent

Locations

Country	Name	City	State
China	The PLA General Hospital	BeiJing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sino Medical Sciences Technology Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	1 or 2 months
Secondary	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	1 or 2 months
Secondary	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	1 or 2 months
Secondary	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	1 or 2 months
Secondary	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	1 or 2 months
Secondary	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	1 or 2 months
Secondary	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	1 or 2 month
Secondary	Binary Restenosis (DS =50%)	All measurements will be made of the in-stent, in-segment, proximal and distal stent margins.	1 or 2 months
Secondary	Acute success rate	It includes the device success,lesion success and procedural success.	up to 7 days
Secondary	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.	1 or 2, 3, 6 months, 1 year, 2 years
Secondary	Stent thrombosis according to the ARC definitions	Definite and probable stent thrombosis during acute, subacute, later and very late phase.	1 or 2, 3, 6 months, 1 year, 2 years
Secondary	bleeding events		1 or 2, 3, 6 months, 1 year, 2 years