Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-03 @ 6:50 PM
Study NCT ID:
NCT02469532
Status:
COMPLETED
Last Update Posted:
2018-03-08
First Post:
2015-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes
Sponsor:
Mercator MedSystems, Inc.
Organization:
Study Overview
Official Title:
DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes
Status:
COMPLETED
Status Verified Date:
2018-03
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:
This is a prospective, multi-center, observational registry to document the baseline, 24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after femoropopliteal angioplasty or atherectomy-based revascularization procedures.
Detailed Description:
This is a prospective, multi-center, observational registry to document the baseline, 24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after femoropopliteal angioplasty or atherectomy-based revascularization procedures.
1. To observe the femoropopliteal revascularization outcomes post-angioplasty and/or atherectomy and to observe potential correlation between patency outcomes and the levels of MCP-1, C-reactive protein and MMP-9 from baseline to 24 hours and 30 days post-procedure.
2. To provide a comparator dataset to the investigational DANCE trial, which has the same enrollment criteria as this observational trial but includes the investigational use of a local drug therapy to limit inflammation caused by mechanical revascularization.
1. To observe the femoropopliteal revascularization outcomes post-angioplasty and/or atherectomy and to observe potential correlation between patency outcomes and the levels of MCP-1, C-reactive protein and MMP-9 from baseline to 24 hours and 30 days post-procedure.
2. To provide a comparator dataset to the investigational DANCE trial, which has the same enrollment criteria as this observational trial but includes the investigational use of a local drug therapy to limit inflammation caused by mechanical revascularization.
Study Oversight
Has Oversight DMC:
False
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?: