Peripheral Registry of Endovascular Clinical Outcomes "The PRIME Registry"

Completed

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

• Registration Number: NCT02786173
• Lead Sponsor: Metro Health, Michigan

Brief 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-30
• Primary Completion: 2020-12
• Study Completion: 2021-11-05
• Status Verified: 2022-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amputation free survival rates	At 36 month follow-up visit

Secondary Outcome Measures

Name	Time	Method
Access site and procedural complications	At 36 month follow-up visit
Target lesion revascularization	At 36 month follow-up visit
Procedural success	At 36 month follow-up visit
Target vessel revascularization	At 36 month follow-up visit

Trial Locations

Locations (6)

Cox Health; 🇺🇸 Springfield, Missouri, United States

The Hospitals of Providence; 🇺🇸 El Paso, Texas, United States

Orlando Health; 🇺🇸 Orlando, Florida, United States

Prairie Heart; 🇺🇸 Springfield, Illinois, United States

Metro Health Hospital; 🇺🇸 Wyoming, Michigan, United States

Rex Healthcare; 🇺🇸 Raleigh, North Carolina, United States