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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00016666

Enrollment

Registered

2019-01-31

Start date

2019-02-04

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I70.1

Interventions

Group 1: Percutaneous transluminal renal angioplasty (PTRA) and stenting procedure will be performed according to investigator’s standard practice. Follow up data will be collected if available at dis

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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. In addition to the physical examination, the parameters are recorded by ultrasound. • Residual stenosis (for stenosis) • Vessel sealing (for aneurysms, perforations, ruptures and fistulas) • Frequency of complaints regarding the device • Stent occlusion / restenosis rate (PSV) • Residual trans-stenotic pressure gradient • Time to loss of patency • Freedom from Target Lesion Revascularization (TLR) • Time to return of original symptoms (Event-free survival) Such as hypertension, congestive heart failure, pulmonary edema, time to first reintervention or revision • Change in renal function • Patency (primary, primary-assisted, secondary)	—

Measure

Time frame

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

—

Countries

Germany, Italy

Contacts

Public ContactMartin Schirling

Bentley InnoMed GmbH

m.schirling@bentley.global+49 7471 9999 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026