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）

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Sino Medical Sciences Technology Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	BuMA Supreme™ stent
DEVICE	Xience V/Prime stent

Timeline

• Start date: 2016-06-15
• Primary completion: 2017-05-11
• Completion: 2021-03-03
• First posted: 2016-04-21
• Last updated: 2021-10-13

Locations

1 site across 1 country: China