Peripheral Registry of Endovascular Clinical Outcomes "The PRIME Registry" (PRIME)

Peripheral Registry of Endovascular Clinical Outcomes

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).

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health
  • Illinois
    • Springfield, Illinois, United States, 62701
      • Prairie Heart
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Metro Health Hospital
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Cox Health
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Rex Healthcare
  • Texas
    • El Paso, Texas, United States, 79902
      • The Hospitals of Providence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are to receive or have received lower extremity endovascular treatment for peripheral artery disease.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amputation free survival rates	At 36 month follow-up visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Access site and procedural complications	At 36 month follow-up visit
Target lesion revascularization	At 36 month follow-up visit
Target vessel revascularization	At 36 month follow-up visit
Procedural success	At 36 month follow-up visit

Collaborators and Investigators

• Sponsor: Metro Health, Michigan
• Collaborators: Boston Scientific Corporation; C. R. Bard; Cardiovascular Systems Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): November 5, 2021

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 30, 2016

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: PAD; Observational; PVD; CLI; PRIME; PRIME Registry
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: PRIME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO