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The Vascutek Rapidax™ II Post Market Surveillance Registry

Sponsor
Vascutek Ltd. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01977508
Collaborator
(none)
24
Enrollment
3
Locations
33
Duration (Months)
8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Multicentre, prospective, observational post-market registry. To monitor and collect data on the post-market clinical safety and performance of the Vascutek Rapidax II Vascular Access Graft.

Condition or Disease Intervention/Treatment Phase
  • Device: ePTFE vascular access grafts

Detailed Description

At least 10 patients who have been implanted with a Rapidax II Vascular Access Graft for haemodialysis applications in patients with End Stage Renal Disease (ESRD), who are undergoing or are scheduled to begin haemodialysis and require implant of a prosthetic graft.

Primary End Points:Safety and Performance

  • Secondary patency at 6 months post implant (Performance).(access survival until abandonment). The interval from time of implant to abandonment or time of measurement of patency, including intervention to re-establish the functionality of the thrombosed access

  • Secondary patency at 12 months post implant (Performance.(access survival until abandonment). The interval from time of implant to abandonment or time of measurement of patency, including intervention to re-establish the functionality of the thrombosed access

  • Freedom from device related Serious Adverse Events at 6 and 12 months (Safety)

Secondary End Points: Safety and performance

  • Primary patency at 6 months post implant (Performance. (intervention free access survival). The interval from time of implant to any intervention designed to maintain or re-establish patency or to access thrombosis

  • Primary patency at 12 months post implant (Performance).(intervention free access survival). The interval from time of implant to any intervention designed to maintain or re-establish patency or to access thrombosis

  • Assisted primary patency at 6 months (Performance. (thrombosis free access survival). The interval from time of implant to intervention to maintain patency prior to the occurrence of thrombosis

  • Freedom from device related Serious Adverse Events at 6 and 12 months

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
24 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Vascutek Rapidax™ II Post Market Surveillance Registry
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
haemodialysis vascular access using ePTFE grafts

Device: ePTFE vascular access grafts
Other Names:
  • RapidaxTM II Vascular access graft

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and Performance [6 months]

      Secondary patency at 6 months post implant (Performance)

    2. Safety and Performance [12 months]

      Secondary patency at 12 months post implant (Performance)

    3. Safety and Performance [12 months]

      Freedom from device related Serious Adverse Events at 6 and 12 months (Safety)

    Secondary Outcome Measures

    1. Safety and Performance [6 months]

      Primary patency at 6 months post implant (Performance)

    2. Safety and Performance [12 months]

      Primary patency at 12 months post implant (Performance) •

    3. Safety and Performance [12 months]

      Assisted primary patency at 6 months (Performance) •

    4. Safety and Performance [12 months]

      Freedom from device related Serious Adverse Events at 6 and 12 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Subject is ≥ 18 and ≤ 90 years old

    2. Subject has a life expectancy of at least 12 months

    3. Subject is scheduled to undergo placement of a new straight or loop arm arteriovenous haemodialysis access graft

    4. The subject is willing and able to comply with the protocol and associated follow up requirements

    5. Subjects must have agreed for their data to be entered into the registry as per the local hospital consent procedure

    Exclusion Criteria:

    1. Known allergy or sensitivity to ePTFE

    2. Subject unwilling or unable to comply with the protocol

    3. Life expectancy of less than 1 year

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saale-Unstrut Klinikum Naumburg Naumburg Germany
    2 Thüringen Kliniken Georguis Saale Germany
    3 Medinos Klinik Sonneberg Sonneberg Germany

    Sponsors and Collaborators

    • Vascutek Ltd.

    Investigators

    • Principal Investigator: Bernd Lobenstein, Saale-Unstrut Klinikum Naumburg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vascutek Ltd.
    ClinicalTrials.gov Identifier:
    NCT01977508
    Other Study ID Numbers:
    • VAG-001
    First Posted:
    Nov 6, 2013
    Last Update Posted:
    May 20, 2016
    Last Verified:
    May 1, 2016
    Keywords provided by Vascutek Ltd.
    Vascular access grafts
    Haemodialysis
    Additional relevant MeSH terms:
    Kidney Diseases
    Kidney Failure, Chronic

    Study Results

    No Results Posted as of May 20, 2016