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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
Sponsor:
Collaborator:
Klinikum Ernst von Bergmann Augenklinik Laserzentrum
Information provided by (Responsible Party):
B. Braun Melsungen AG

Brief 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.

Condition or disease Intervention/treatment
Coronary Artery Disease (CAD) Device: Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 491 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: Post MArket Surveillance of SeQuent Please Neo With ScORing Balloon Lesion Preparation in Real WorlD Patients
Study Start Date : October 2015
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Intervention Details:
  • Device: Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation
    Percutaneous Coronary Intervention
    Other Name: SeQuent® Please Neo Drug Coated Balloon, NSE Alpha Scoring Balloon


Primary Outcome Measures :
  1. Target Vessel Failure [ Time Frame: 9 months ]
    Target Vessel Failure = TLR + Myocardial Infarction (MI) + cardiac death


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with coronary artery disease, specifically with in-stent restenosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554292


Locations
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Germany
Klinikum Ernst von Bergmann
Potsdam, Germany, 14467
Sponsors and Collaborators
B. Braun Melsungen AG
Klinikum Ernst von Bergmann Augenklinik Laserzentrum
Investigators
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Principal Investigator: Klaus Bonaventura, MD Klinikum Ernst von Bergmann

Additional Information:

Publications of Results:

Other Publications:
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Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT02554292     History of Changes
Other Study ID Numbers: AAG-O-A-1507
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases