NCT03129750

Safety and Efficacy of DCB for the Treatment of SFA Ischemic Vascular Disease in Patients With TASC C and D Lesions

Safety and Efficacy of the Drug Coated Balloon (DCB) for the Treatment of the Superficial Femoral Artery (SFA) Ischemic Vascular Disease in Symptomatic Patients Presenting With TASC C and D Lesions: a Pilot Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Ettore Sansavini Health Science Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is aimed at collecting preliminary safety and efficacy data related to the use of Drug Coated Balloon (DCB) technology for the treatment of symptomatic Superficial Femoral Artery (SFA) ischemic vascular disease in patients presenting with long lesions. The present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (CE marked) DCB currently available on the market.

Detailed description

The present study is designed as a prospective, open label, observational study. The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done. Patients elected for endovascular revascularization with DCB will be asked their written consent to the use of their personal data. Revascularization will be performed as per standard procedure of the sites. After discharge all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days), 12 months (±30 days), 24 and 36 months (±30 days). Angiographic follow-up will be performed in symptomatic patients, as clinically indicated.

Conditions

• PAD

Interventions

Type	Name	Description
DEVICE	Drug Coated Balloon	Peripheral PTA with a drug coated balloon

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-09-01
• Completion: 2020-09-01
• First posted: 2017-04-26
• Last updated: 2017-06-08

Locations

10 sites across 1 country: Italy