MedTrace Logo

The Safety and Efficacy of Biolimus in the Treatment of Patients With in Stent Restenosis

NCT04733443 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2023-11-18

No results posted yet for this study

Summary

This study consisted of a randomized controlled trial group and a long balloon observation group.

In the randomized control group, 280 subjects with in-stent restenosis were planned to be recruited and randomly assigned to the test group and the control group in a 1:1 ratio; 30 consecutive subjects will be enrolled in the long balloon observation group, using graceful molimus release coronary balloon catheter with length of 45mm; All 310 subjects were followed up at baseline, surgery, discharge, 1 month after surgery, 6 months after surgery, 9 months after surgery, 1, 2 and 3 years after surgery, and angiography was performed at 9 months after surgery.

Conditions

Interventions

DEVICE

Biolimus

140 patients who met the inclusion/exclusion criteria for in-stent restenosis were enrolled and assigned to the Biolimus treatment group

DEVICE

SeQuent® Please Neo

140 patients who met the inclusion/exclusion criteria for in-stent restenosis were enrolled and assigned to the SeQuent® Please Neo treatment group

Sponsors & Collaborators

  • JW Medical Systems Ltd

    lead INDUSTRY

Principal Investigators

  • Yundai Chen, Ph.D · The First Medical Center of the PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2023-01-18
Completion
2025-02-18

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04733443 on ClinicalTrials.gov