Trials / Completed
CompletedNCT02554292
Post Market Surveillance of SeQuent Please Neo With Scoring Balloon
Post MArket Surveillance of SeQuent Please Neo With ScORing Balloon Lesion Preparation in Real WorlD Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 481 (actual)
- Sponsor
- B. Braun Melsungen AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of the SeQuent® Please Neo post market surveillance is to assess the clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloon before the use of the paclitaxel-coated SeQuent® Please Neo in an 'all comer'/ 'real world' setting for the treatment of in-stent restenosis and de-novo lesions.
Detailed description
The aim of this post market surveillance is to document the safety and efficacy of the drug-coated balloon Sequent® Please Neo in combination with the NSE Alpha scoring balloon in the treatment of both in-stent restenosis and de-novo lesions in native coronary arteries with reference diameters of 2.5 mm up to 4.0 mm with lesion lengths of 30 mm for procedural success and preservation of vessel patency
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation | Percutaneous Coronary Intervention |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2018-12-01
- Completion
- 2019-12-01
- First posted
- 2015-09-18
- Last updated
- 2020-03-30
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02554292. Inclusion in this directory is not an endorsement.