NCT02786173

Peripheral Registry of Endovascular Clinical Outcomes "The PRIME Registry"

Peripheral Registry of Endovascular Clinical Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Metro Health, Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The PRIME Registry is a multi-center, observational study designed to evaluate immediate and long-term outcomes (36 months) of endovascular revascularization in patients with critical limb ischemia (CLI) and advanced peripheral artery disease (PAD).

Detailed description

The Peripheral RegIstry of Endovascular Clinical OutcoMEs (PRIME Registry) represents the collaborative effort among seven centers across the US with the goal of reaching 10 sites globally. PRIME explores all aspects of advanced peripheral arterial disease (PAD) and critical limb ischemia (CLI) care including the collection of comprehensive clinical, diagnostic, procedural, and follow-up data for three years following an index endovascular procedure. Data collection activities began in January of 2013 with the goal of collecting data on 1500 subjects. Analysis of this multi-site registry will produce generalizable findings that describe the clinical epidemiology and management practices of advanced PAD and CLI patients.

Conditions

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Critical Limb Ischemia

Timeline

• Start date: 2013-01-01
• Primary completion: 2020-12-01
• Completion: 2021-11-05
• First posted: 2016-05-30
• Last updated: 2023-03-13

Locations

6 sites across 1 country: United States