Post Market Surveillance of SeQuent Please Neo With Scoring Balloon (PASSWORD)
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ClinicalTrials.gov Identifier: NCT02554292
Recruitment Status :
Active, not recruiting
First Posted : September 18, 2015
Last Update Posted : November 13, 2019
B. Braun Melsungen AG
Klinikum Ernst von Bergmann Augenklinik Laserzentrum
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.
Condition or disease
Coronary Artery Disease (CAD)
Device: Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation
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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with coronary artery disease, specifically with in-stent restenosis
patients with in-stent restenosis and de-novo lesions in coronary arteries
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
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