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

Conditions: I70.1
Atherosclerosis of renal artery

Registration Number: DRKS00016666

Lead Sponsor: Bentley InnoMed GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 32

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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety<br>- Frequency of major adverse events (MAE) at stent implantation as well as after 6 and 12 months. Yearly follow up up to 60 months.<br><br>Performance<br>- Technical: Successful stent graft placement

Secondary Outcome Measures

Name	Time	Method
The following secondary endpoints are recorded at the time of discharge, as well as after 6 and 12 months as part of routine follow-up.<br>In addition to the physical examination, the parameters are recorded by ultrasound.<br><br>• Residual stenosis (for stenosis)<br>• Vessel sealing (for aneurysms, perforations, ruptures and fistulas)<br>• Frequency of complaints regarding the device<br>• Stent occlusion / restenosis rate (PSV)<br>• Residual trans-stenotic pressure gradient<br>• Time to loss of patency<br>• Freedom from Target Lesion Revascularization (TLR)<br>• Time to return of original symptoms (Event-free survival)<br>Such as hypertension, congestive heart failure, pulmonary edema, time to first reintervention or revision<br>• Change in renal function<br>• Patency (primary, primary-assisted, secondary)