Post Market Surveillance of SeQuent Please Neo With Scoring Balloon

Coronary Artery Disease (CAD) Clinical Trial

— PASSWORD  

Official title:

Post MArket Surveillance of SeQuent Please Neo With ScORing Balloon Lesion Preparation in Real WorlD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554292
• Other study ID #: AAG-O-A-1507
• Status: Completed
• Start date: October 2015
• Est. completion date: December 2019

Study information

• Verified date: March 2020
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 481
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)

Intervention

Device:
• Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation
Percutaneous Coronary Intervention

Locations

Country	Name	City	State
Germany	Klinikum Ernst von Bergmann	Potsdam

Sponsors (2)

Lead Sponsor	Collaborator
B. Braun Melsungen AG	Klinikum Ernst von Bergmann Augenklinik Laserzentrum

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Almalla M, Schröder JW, Pross V, Stegemann E, Marx N, Hoffmann R. Everolimus-eluting versus paclitaxel-eluting stents for treatment of bare metal stent restenosis. Am J Cardiol. 2011 Aug 15;108(4):518-22. doi: 10.1016/j.amjcard.2011.03.080. Epub 2011 May 31. — View Citation

Byrne RA, Neumann FJ, Mehilli J, Pinieck S, Wolff B, Tiroch K, Schulz S, Fusaro M, Ott I, Ibrahim T, Hausleiter J, Valina C, Pache J, Laugwitz KL, Massberg S, Kastrati A; ISAR-DESIRE 3 investigators. Paclitaxel-eluting balloons, paclitaxel-eluting stents, — View Citation

Kufner S, Cassese S, Valeskini M, Neumann FJ, Schulz-Schüpke S, Hoppmann P, Fusaro M, Schunkert H, Laugwitz KL, Kastrati A, Byrne RA; ISAR-DESIRE 3 Investigators. Long-Term Efficacy and Safety of Paclitaxel-Eluting Balloon for the Treatment of Drug-Elutin — View Citation

Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wöhrle J. A randomized, multicenter, single-blinded trial compar — View Citation

Wöhrle J, Zadura M, Möbius-Winkler S, Leschke M, Opitz C, Ahmed W, Barragan P, Simon JP, Cassel G, Scheller B. SeQuentPlease World Wide Registry: clinical results of SeQuent please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study. J Am Coll Cardiol. 2012 Oct 30;60(18):1733-8. doi: 10.1016/j.jacc.2012.07.040. Epub 2012 Oct 3. — View Citation

Xu B, Gao R, Wang J, Yang Y, Chen S, Liu B, Chen F, Li Z, Han Y, Fu G, Zhao Y, Ge J; PEPCAD China ISR Trial Investigators. A prospective, multicenter, randomized trial of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of drug- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Vessel Failure	Target Vessel Failure = TLR + Myocardial Infarction (MI) + cardiac death	9 months
Secondary	procedural success rate	lesion crossing success in in-stent restenotic lesions	intraprocedural
Secondary	Target Lesion Revascularization rate = Re-PCI + CABG(TLR)		9 months
Secondary	cardiac death	death of cardiac or unknown causes	9 months
Secondary	Rate of coronary arterial bypass grafting (CABG)		9 months
Secondary	rate of myocardial infarction		9 months