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Clinical Trials/DRKS00016666
DRKS00016666
Completed
Not Applicable

An observational multicentre study to confirm the safety and performance of the BeGraft Peripheral Stent Graft System (BGP) in renal arteries - BGP-2, BGP in renal arteries

Bentley InnoMed GmbH0 sites32 target enrollmentJanuary 31, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
I70.1
Sponsor
Bentley InnoMed GmbH
Enrollment
32
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 31, 2019
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients with an indication for intraluminal chronic placement of a BeGraft Peripheral Stent Graft System in renal arteries or patients who have already received a BeGraft Peripheral Stent Graft System can be included if:
  • The treatment is for restoring and improving the patency or treating aneurysms, acute perforations, acute ruptures or fistulas
  • They have a signed data privacy consent
  • Criteria for renal interventions is given according to relevant guidelines

Exclusion Criteria

  • Patients with any contraindication according to the IFU (instructions for use)
  • Intolerance to antiplatelet therapy
  • Lytic agent administered in the past 30 days
  • History of bleeding diathesis
  • Coagulopathy
  • Gastrointestinal hemorrhage within the past 6 months
  • Life expectancy less than 1 year
  • Dialytic patients
  • BGP is used in combination with an EVAR/S device for the treatment of an aorta aneurysm
  • BGP as a bridging stent

Outcomes

Primary Outcomes

Not specified

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