NCT04299906

SOLARIS Peripheral PMCF Trial

Physician-Initiated PMCF Trial Investigating the Solaris Vascular Stent Graft for the Treatment of Iliac Lesions - SOLARIS Peripheral PMCF Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Dr. Sabrina Overhagen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the Solaris Vascular Stent Graft (Scitech) in clinical settings when used according to the indications of the IFU.

Conditions

• Peripheral Arterial Disease
• Iliac Artery Stenosis
• Common Femoral Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Solaris Vascular Stent Graft	Solaris Vascular Stent Graft for treatment of Iliac Lesions

Timeline

• Start date: 2021-05-17
• Primary completion: 2024-11-30
• Completion: 2024-12-30
• First posted: 2020-03-09
• Last updated: 2023-11-15

Locations

10 sites across 3 countries: Germany, Italy, Netherlands