Trials / Completed
CompletedNCT02944890
Compare the Efficacy and Safety of RESTORE DEB and SeQuent® Please in Chinese Patient With Coronary In-stent Restenosis
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-stent Restenosis (ISR)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Drug Eluting Balloon Catheters(RESTORE DEB） | |
| DEVICE | Drug Eluting Balloon Catheters(SeQuent® Please） |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2018-06-01
- Completion
- 2019-05-01
- First posted
- 2016-10-26
- Last updated
- 2019-07-29
Locations
14 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02944890. Inclusion in this directory is not an endorsement.