NCT02469532

DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: Mercator MedSystems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Balloon Angioplasty	Device: Balloon Angioplasty Selection is driven by preference of the operator
DEVICE	Atherectomy System	Device: Orbital or Directional or Laser Atherectomy Systems Atherectomy selection is driven by preference of the operator

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-10-01
• Completion: 2018-01-01
• First posted: 2015-06-11
• Last updated: 2018-03-08

Locations

6 sites across 1 country: United States