Post Market Surveillance of SeQuent Please Neo With Scoring Balloon (PASSWORD)

B. Braun

Status: Completed

Conditions: Coronary Artery Disease (CAD)

Treatments: Device: Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02554292

AAG-O-A-1507

Details and patient eligibility

About

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.

Full 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

Enrollment: 481 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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