Clinical Trial: Compare the Efficacy and Safety of RESTORE DEB and SeQuent® Please in Chinese Patient With Coronary In-stent Restenosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multicenter, Randomized, Controlled Study to Compare the Efficacy and Safety of 2 Types of Drug Eluting Balloon Catheters (RESTORE DEB and SeQuent® Please) in Chinese Patient With Coronary In-s
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment and maintaining the vessels unobstructed in the treatment of coronary in-stent restenosis compared with a product of the same category (SeQuent® Please).
Detailed Summary:
Sponsor: ZhuHai Cardionovum Medical Device Co., Ltd.
Current Primary Outcome: In-segment late lumen loss of the target lesion [ Time Frame: 9 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The success rate of intervention treatment: including device success, lesion success and clinical success [ Time Frame: 1-2 days ]
- Occurrence rate of restenosis in the target lesions [ Time Frame: 9 months after the operation ]
- Target lesion revascularization (TLR) rate [ Time Frame: 1, 6, 9, and 12 months after the operation ]
- Target vessel revascularization (TVR) rate [ Time Frame: 1, 6, 9, and 12 months after the operation ]
- Target lesion failure (TLF) rate [ Time Frame: 1, 6, 9, and 12 months after the operation ]
- Occurrence rate of major adverse cardiovascular events [ Time Frame: 1, 6, 9, and 12 months after the operation ]
- All adverse events and severe adverse events [ Time Frame: 1, 6, 9, and 12 months after the operation ]
Original Secondary Outcome: Same as current
Information By: ZhuHai Cardionovum Medical Device Co., Ltd.
Dates:
Date Received: October 24, 2016
Date Started: May 2016
Date Completion: May 2018
Last Updated: April 11, 2017
Last Verified: October 2016