Peripheral Registry of Endovascular Clinical Outcomes "The PRIME Registry"

Metro Health, Michigan

Status: Completed

Conditions: Peripheral Vascular Disease; Critical Limb Ischemia; Peripheral Arterial Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02786173

PRIME

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are to receive or have received lower extremity endovascular intervention
• Rutherford III-VI Classification
• Ability to provide informed consent within 30 day prior to 60 days post index endovascular intervention.
• Ability to follow up at enrollment site.

Exclusion criteria

• Inability or unwillingness to consent for participation in the registry.

Trial design