Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 2:24 AM
Study NCT ID:
NCT03129750
Status:
UNKNOWN
Last Update Posted:
2017-06-08
First Post:
2016-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of DCB for the Treatment of SFA Ischemic Vascular Disease in Patients With TASC C and D Lesions
Sponsor:
Ettore Sansavini Health Science Foundation
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: