Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-20 @ 3:32 PM
Study NCT ID:
NCT01071460
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
2010-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Efficacy and Safety of the FlexStent Self-Expanding Stent System
Sponsor:
Provascular GmbH
Organization:
Study Overview
Official Title:
The FlexStent-Registry, Evaluation of Efficacy and Safety of the FlexStent Femoropopliteal Self-Expanding Stent System
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
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:
Purpose of this registry is to determine the efficacy and safety of the self-expanding, extra flexible FlexStent in patient with superficial femor/popliteal artery disease.
The stent has been developed to cope with the extreme requirements of the femoral artery/knee artery and is approved for usage at humans (EC-certified). It is designed to treat narrows of the femoral- and knee artery.
100 patients at 5 German hospital shall be enrolled. After stent implantation follow-up visits at 6 and 12 month take place.
The stent has been developed to cope with the extreme requirements of the femoral artery/knee artery and is approved for usage at humans (EC-certified). It is designed to treat narrows of the femoral- and knee artery.
100 patients at 5 German hospital shall be enrolled. After stent implantation follow-up visits at 6 and 12 month take place.
Detailed Description:
Peripheral arterial disease (PAD) represents a major challenge to physicians in treating the Superficial Femoral (SFA) and Popliteal arteries. These arteries represent a harsh environment for any endovascular device. This disease is characterized by long occlusions with relatively low flow and with the vessels exposed to enormous mechanical stress. During flexing of the knee, the SFA/Popliteal arteries can bend, rotate, elongate and compress dramatically. An ideal stent designed for use in the SFA/Popliteal arteries would offer great ranges of movement while adequately supporting the arteries.
The FlexStent® stent provides a great range of motions for a highly flexible femoral artery while adequately supporting the vessel. The intended use for the FlexStent® stent is for the treatment of symptomatic femoropopliteal disease, primarily for atherosclerotic de novo native superficial femoral artery lesions.
The intent of this clinical registry is to demonstrate the efficacy and safety of the FlexStent® stent in patients with superficial femoral/ popliteal artery disease.
Hypothesis: the FlexStent® will be safe and efficacious in treating SFA/popliteal artery diseases.
Primary object: evaluation of efficacy of the FlexStent® measured by the in-stent restenosis using DUS following treatment, 6 and 12 MFU visits.
The FlexStent® stent provides a great range of motions for a highly flexible femoral artery while adequately supporting the vessel. The intended use for the FlexStent® stent is for the treatment of symptomatic femoropopliteal disease, primarily for atherosclerotic de novo native superficial femoral artery lesions.
The intent of this clinical registry is to demonstrate the efficacy and safety of the FlexStent® stent in patients with superficial femoral/ popliteal artery disease.
Hypothesis: the FlexStent® will be safe and efficacious in treating SFA/popliteal artery diseases.
Primary object: evaluation of efficacy of the FlexStent® measured by the in-stent restenosis using DUS following treatment, 6 and 12 MFU visits.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 147-2009-06072009 | OTHER | Ethic Committee at the University of Leipzig, Germany | View |