Ignite Creation Date:
2024-05-06 @ 2:19 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02011984
Status:
UNKNOWN
Last Update Posted:
2015-02-11
First Post:
2013-11-15
Brief Title:
Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system
Sponsor:
Eucatech AG
Organization:
Eucatech AG
Study Overview
Official Title:
Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system in Peripheral Superficial Femoral Arteries
Status:
UNKNOWN
Status Verified Date:
2015-02
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:
RECAM
Brief Summary:
Non-randomized multicenter post-market study to confirm the long-term safety and effectiveness of the CE-approved Camouflage-coated self-expandable RESISTANT Camouflage stent system for revascularization of de novo stenotic lesions in the superficial femoral artery in 100 compliant patients suitable for stent angioplasty
The CE-approved device will be used according to its intended use Beyond the standard of care no further interventions are scheduled Therefore this trial is subject to the exception to the rule 23b of the German Medical Device Act MPG which includes the national implementation of EC directive 9342EEC
The CE-approved device will be used according to its intended use Beyond the standard of care no further interventions are scheduled Therefore this trial is subject to the exception to the rule 23b of the German Medical Device Act MPG which includes the national implementation of EC directive 9342EEC
Detailed Description:
The aim of this non-randomized post-market clinical follow-up study is to confirm long-term safety and effectiveness of the CE-approved Camouflage-coated self expandable RESISTANT Camouflage stent system for revascularization of de novo stenotic lesions in superficial femoral artery in 120 compliant patients suitable for stent angioplasty The primary end point is the target lesion revascularization after 12 months Further follow-ups are scheduled at discharge 30 days 6 and 24 months
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECT024ResiCSfaRegV10 | OTHER | CERES | None |