Peripheral Arterial DiseasePRIMENCT02786173
Peripheral Registry of Endovascular Clinical Outcomes "The PRIME Registry"
An observational study of Peripheral Arterial Disease and Peripheral Vascular Disease, run by Metro Health, Michigan at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- How many people
- 1,000 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2013to 5 Nov 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are to receive or have received lower extremity endovascular treatment for peripheral artery disease.
Who may be able to join
- 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.
Who cannot join
- Inability or unwillingness to consent for participation in the registry.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The Hospitals of Providence
El Paso, Texas, 79902
Orlando Health
Orlando, Florida, 32806
Rex Healthcare
Raleigh, North Carolina, 27607
Prairie Heart
Springfield, Illinois, 62701
Cox Health
Springfield, Missouri, 65807
Metro Health Hospital
Wyoming, Michigan, 49519
About this study
Official title: 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).
Read the 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.
- Keywords
- PRIME, PAD, PVD, Observational, CLI, PRIME Registry
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation free survival rates
Measured: At 36 month follow-up visit
Secondary outcomes (4)
Access site and procedural complications
Measured: At 36 month follow-up visit
Target lesion revascularization
Measured: At 36 month follow-up visit
Target vessel revascularization
Measured: At 36 month follow-up visit
Procedural success
Measured: At 36 month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2020
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Metro Health, Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- C. R. Bard, Abbott Medical Devices, Boston Scientific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786173
- Sponsor's protocol ID
- PRIME
- Acronym
- PRIME
- Status last verified
- Mar 2022
- First submitted
- 17 May 2016
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Registry of Endovascular Clinical Outcomes
- ClinicalTrials.gov ID
- NCT02786173
- Acronym / sponsor ID
- PRIME / PRIME
- Keywords
- PRIME, PAD, PVD, Observational, CLI, PRIME Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Metro Health, MichiganUniversity, hospital or other
- Collaborators
- C. R. Bard, Abbott Medical Devices, Boston Scientific Corporation
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 30 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are to receive or have received lower extremity endovascular treatment for peripheral artery disease.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability or unwillingness to consent for participation in the registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amputation free survival rates
Time frame: At 36 month follow-up visit
4 secondary outcomes
Access site and procedural complications
Time frame: At 36 month follow-up visit
Target lesion revascularization
Time frame: At 36 month follow-up visit
Target vessel revascularization
Time frame: At 36 month follow-up visit
Procedural success
Time frame: At 36 month follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Peripheral Vascular Disease, run by Metro Health, Michigan at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation free survival rates (time frame: At 36 month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.