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

March 27, 2020 updated by: B. Braun Melsungen AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

481

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Potsdam, Germany, 14467
        • Klinikum Ernst von Bergmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with coronary artery disease, specifically with in-stent restenosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Vessel Failure
Time Frame: 9 months
Target Vessel Failure = TLR + Myocardial Infarction (MI) + cardiac death
9 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B. Braun Melsungen AG

Collaborators

Ernst von Bergmann Hospital

Investigators

  • Principal Investigator: Klaus Bonaventura, MD, Klinikum Ernst von Bergmann

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-A-1507

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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