Post Market Surveillance of SeQuent Please Neo With Scoring Balloon

Completed

• Conditions: Coronary Artery Disease (CAD)

• Registration Number: NCT02554292
• Lead Sponsor: B. Braun Melsungen AG

Brief 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

Study Timeline

• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Study Start: 2015-10
• Primary Completion: 2018-12
• Study Completion: 2019-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 481

Inclusion Criteria

• patients with in-stent restenosis and de-novo lesions in coronary arteries

Exclusion Criteria

• Intolerance to paclitaxel and/or the balloon coating
• Allergy to components of the balloon coating
• Pregnancy and lactation
• Complete occlusion of the treatment vessel
• Severely calcified stenosis
• Cardiogenic shock
• Risk of an intraluminal thrombus
• Haemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Vessel Failure	9 months	Target Vessel Failure = TLR + Myocardial Infarction (MI) + cardiac death

Secondary Outcome Measures

Name	Time	Method
Target Lesion Revascularization rate = Re-PCI + CABG(TLR)	9 months
procedural success rate	intraprocedural	lesion crossing success in in-stent restenotic lesions
cardiac death	9 months	death of cardiac or unknown causes
Rate of coronary arterial bypass grafting (CABG)	9 months
rate of myocardial infarction	9 months

Trial Locations

Locations (1)

Klinikum Ernst von Bergmann; 🇩🇪 Potsdam, Germany