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

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ClinicalTrials.gov Identifier: NCT02786173
Recruitment Status : Active, not recruiting
First Posted : May 30, 2016
Last Update Posted : February 25, 2021
Sponsor:
Collaborators:
C. R. Bard
Cardiovascular Systems Inc
Boston Scientific Corporation
Information provided by (Responsible Party):
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).

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Peripheral Registry of Endovascular Clinical Outcomes
Actual Study Start Date : January 2013
Actual Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022



Primary Outcome Measures :
  1. Amputation free survival rates [ Time Frame: At 36 month follow-up visit ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are to receive or have received lower extremity endovascular treatment for peripheral artery disease.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786173


Locations
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United States, Florida
Orlando Health
Orlando, Florida, United States, 32806
United States, Illinois
Prairie Heart
Springfield, Illinois, United States, 62701
United States, Michigan
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Missouri
Cox Health
Springfield, Missouri, United States, 65807
United States, North Carolina
Rex Healthcare
Raleigh, North Carolina, United States, 27607
United States, Texas
The Hospitals of Providence
El Paso, Texas, United States, 79902
Sponsors and Collaborators
Metro Health, Michigan
C. R. Bard
Cardiovascular Systems Inc
Boston Scientific Corporation
Additional Information:

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Responsible Party: Metro Health, Michigan
ClinicalTrials.gov Identifier: NCT02786173    
Other Study ID Numbers: PRIME
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Metro Health, Michigan:
PRIME
PAD
PVD
Observational
CLI
PRIME Registry
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Ischemia
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases