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Completed

NCT Number: NCT02786173

Peripheral Registry of Endovascular Clinical Outcomes "The PRIME Registry"

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).

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Critical Limb Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orlando Health, Orlando, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Amputation free survival rates

    Time frame: At 36 month follow-up visit

Secondary outcomes

  1. Access site and procedural complications

    Time frame: At 36 month follow-up visit

  2. Target lesion revascularization

    Time frame: At 36 month follow-up visit

  3. Target vessel revascularization

    Time frame: At 36 month follow-up visit

  4. Procedural success

    Time frame: At 36 month follow-up visit

Sponsors and collaborators

Lead sponsor

Metro Health, Michigan

Other

Collaborators

  • Abbott Medical Devices
  • Boston Scientific Corporation
  • C. R. Bard

Registry information

Official study title

Peripheral Registry of Endovascular Clinical Outcomes

Acronym: PRIME

Important dates

Study start
2013
Primary completion
2020
Study completion
2021
First posted
May 30, 2016
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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