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OpenTrials
Completed

NCT Number: NCT02554292

Post Market Surveillance of SeQuent Please Neo With Scoring Balloon

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.

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Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Ernst von Bergmann

Potsdam, 14467, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation

Device

Percutaneous Coronary Intervention

Other names: SeQuent® Please Neo Drug Coated Balloon, NSE Alpha Scoring Balloon

Primary outcomes

  1. Target Vessel Failure

    Time frame: 9 months

    Target Vessel Failure = TLR + Myocardial Infarction (MI) + cardiac death

Secondary outcomes

  1. procedural success rate

    Time frame: intraprocedural

    lesion crossing success in in-stent restenotic lesions

  2. Target Lesion Revascularization rate = Re-PCI + CABG(TLR)

    Time frame: 9 months

  3. cardiac death

    Time frame: 9 months

    death of cardiac or unknown causes

  4. Rate of coronary arterial bypass grafting (CABG)

    Time frame: 9 months

  5. rate of myocardial infarction

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Collaborators

  • Ernst von Bergmann Hospital

Registry information

Official study title

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

Acronym: PASSWORD

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Sep 18, 2015
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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