The Vascutek Rapidax™ II Post Market Surveillance Registry

NCT01977508 | Terminated

• 1 other identifier: VAG-001
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

End Stage Kidney Disease

Keywords

Vascular access grafts; Haemodialysis

Outcome Measures

Primary Outcomes (3)

• Safety and Performance

  * Secondary patency at 6 months post implant (Performance)

  6 months

• Safety and Performance

  Secondary patency at 12 months post implant (Performance)

  12 months

• Safety and Performance

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

  12 months

Secondary Outcomes (4)

• Safety and Performance

  6 months

• Safety and Performance

  12 months

• Safety and Performance

  12 months

• Safety and Performance

  12 months

Study Arms (1)

haemodialysis vascular access using ePTFE grafts

Device: ePTFE vascular access grafts

Interventions

ePTFE vascular access grafts DEVICE

Also known as: RapidaxTM II Vascular access graft

haemodialysis vascular access using ePTFE grafts

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Subject is ≥ 18 and ≤ 90 years old
• Subject has a life expectancy of at least 12 months
• Subject is scheduled to undergo placement of a new straight or loop arm arteriovenous haemodialysis access graft
• The subject is willing and able to comply with the protocol and associated follow up requirements
• Subjects must have agreed for their data to be entered into the registry as per the local hospital consent procedure

You may not qualify if:

• Known allergy or sensitivity to ePTFE
• Subject unwilling or unable to comply with the protocol
• Life expectancy of less than 1 year

Sponsors & Collaborators

• Vascutek Ltd.: lead

Study Sites (3)

Saale-Unstrut Klinikum Naumburg

Naumburg, Germany

Location

Thüringen Kliniken Georguis

Saale, Germany

Location

Medinos Klinik Sonneberg

Sonneberg, Germany

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernd Lobenstein

  Saale-Unstrut Klinikum Naumburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: November 6, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 20, 2016

Record last verified: 2016-05

Locations

DE (3)