Peripheral Registry of Endovascular Clinical Outcomes
Conditions: Peripheral Arterial Disease, Peripheral Vascular Disease, Critical Limb Ischemia
Sponsor: Metro Health, Michigan

 
 
 
 
PRIME Registry 
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Peripheral Registry of Endovascular Clinical Outcomes 
“The PRIME Registry” 
NCT02786173 
February 19. 2016 
 
1. Background/Introduction: 
Peripheral Vascular Disease (PVD) is an epidemic alarmingly on the rise and seriously 
impacting many individual’s quality of life. It is estimated that 20% of patients >75 years will 
be living with the disease by the year 2030(1).  Critical Limb Ischemia (CLI), a serious form of 
PVD, is a severe blockage in the arteries of the lower extremities which markedly reduces 
blood-flow.  CLI is a chronic condition that results in severe pain in the feet and toes and is 
commonly coupled with multiple co-morbidities, including, but not limited to, obesity, 
hypertension, diabetes, and increased age.  With the increasing prevalence of PVD in an 
aging population, and the limitations of vascular surgery in patients with significant 
comorbidities, operators are gravitating more toward less invasive endovascular therapy.  
Endovascular therapy and vascular surgery have been proven equivalent in patients with 
CLI(2). 
 
Patients with CLI can also progress to amputation.  Amputations carry a poor prognosis with 
significant co-morbidity and mortality(3).  Also, there continues to be a significant variation in 
amputation trends across the United States depending on the patient’s location.  This is still 
the case despite the current evidence linking amputations to poor outcomes (4). 
 
In an effort to categorize the anatomical properties of peripheral vascular lesions, the 
Transatlantic Inter-Society Consensus (TASC) divided peripheral lesions in four categories.  
This classification has been recently updated to TASC II(5).  The TASC classification 
however fails to address the complexity of infra-popliteal disease in critical limb ischemia 
patients.  Depending on the patient population, tibial vessels tend to be diffusely diseased.  
With the increasing complexity of CLI patients, operators are tackling these lesions more 
frequently and successfully. 
 
Endovascular revascularization of patients with PVD has evolved dramatically.  New 
technology has arisen due to a better understanding of the atherosclerotic process.  
Treatment modalities encompass balloon angioplasty, stenting, and atherectomy.  New 
modalities of therapy on the horizon include bio-absorbable stents and drug eluting balloons.  
However, data regarding the effectiveness of these modalities in infra-popliteal disease is 
scarce.  A need exists for reporting on real world data, to document short and long term 
outcomes. 
 
Metro Health has developed a peripheral vascular intervention program with the on-going 
goal of being viewed as a center of excellence in the prevention of CLI.  In a quest to 
capture procedure-related details and outcomes related to these approaches, the team at 
Metro Health has developed an outcomes data registry to measure and report on minimally 
invasive endovascular therapies, to treat advanced PVD and CLI.  Multiple institutions will 
collectively contribute data to the registry to advance the understanding of patient 
management and outcomes across all endovascular treatment modalities for advanced PVD 
and CLI. 

 
 
 
 
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2. Objectives: 
The primary objective of PRIME is to systematically document endovascular 
revascularization approaches and patient outcomes with advanced PVD and CLI both in-
hospital and at 1 month, 3 months, 6 months, and annually for 3 years following treatment.  
Secondarily, by collecting and summarizing data describing the management and outcomes 
of these patients, manuscripts will be generated with the goal of improving outcomes.  
Possible examples include:   
• 
A decrease in the major amputation rate 
• 
A decrease in complications associated with peripheral vascular interventions 
• 
Improvements in the quality of life for patients with advanced PVD and CLI 
• 
Development of mathematical tools to assess risk and outcomes 
• 
Development of standardized testing methodologies 
• 
Development of endovascular treatment guidelines 
• 
Development of follow-up protocols for interventional patients with advanced PVD 
and CLI 
• 
The promotion of evidence-based care models 
• 
A reduction in the cost of treating patients with advanced PVD and CLI  
 
3. Methods 
Eligible patients with advanced PVD and CLI at medical centers participating in the 
PRIME Registry will be considered for enrollment in the PRIME registry.   Patients 
will be asked to give consent within 30 days prior and 60 days post index procedure 
to participate.  Once patients are  are enrolled, their demographics, medical history, 
disease-relevant conditions, treatment details and outcomes will be collected for 3 
years.  Please refer to the initial and follow-up data form for variables collected in the 
PRIME registry database.  Data collected meet the requirements of a “Limited Data 
Set” as defined by the United States HIPAA regulations.  Data contain selected 
dates but do not include patient names, initials, or medical record numbers.  Using 
web-based data entry this information will be placed into a secure password 
protected on-line database.  Patients are identified in the database by a unique 
subject record number assigned sequentially by the electronic database and 
unrelated to their medical record number. This number will follow the patient for the 
duration of the study.  These unique numbers can only be matched with patient 
identifiers by the individual site coordinator at each institution.  It is up to the 
individual sites to keep a secure key linking the patient and the subject id number for 
accurate patient follow-up.   
 
Oversight of the PRIME Registry is provided by a Steering Committee and 
Publications Committee.  These committees are comprised of physicians from 
participating sites and the PRIME Coordinating Center.  Decisions regarding 
protocol changes, investigator roles, addition or deletion of participating sites and 
publication of abstracts and manuscripts are made by these committees.  Data used 
in abstracts and manuscripts is aggregate data only.  No identifiable data is used. 
 
Participant data will be stored in PRIME for an indefinite period of time.  Participants 
will not be informed of the results of retrospective research studies involving the use 
of their information contained in PRIME. 
 

 
 
 
 
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4. Human Subjects: 
Individuals to be approached for participation in PRIME will meet each of the following 
inclusion criteria: 
a) Adult male and female patients > 18 years of age.  
b) Patients who are to receive or have received lower extremity endovascular 
intervention  
c) Rutherford III-VI Classification 
d) Ability to provide informed consent within 30 day prior to 60 days post endovascular 
intervention. 
e) Ability to follow up at enrollment site. 
 
Exclusion Criteria: 
Inability or unwillingness to consent for participation in the registry. 
 
Note:  Since participation in PRIME does not involve a risk of physical harm, women of 
childbearing potential will not be queried as to pregnancy status or tested for pregnancy. 
 
5. Recruitment Procedures: 
Patients who meet eligibility criteria at participating PRIME centers will be invited to 
participate in PRIME.  Unless otherwise approved, all consecutive patients will be enrolled 
each month.  Due to the voluntary nature of this registry, sites may have limited resources.  
If all consecutive patients are not able to be enrolled, an alternate method of enrolling 
patients may be utilized, if used consistently and approved by the site’s IRB and the PRIME 
Steering Committee.  Some examples would be enrolling the first 5 or 10 eligible patients 
each month or enrolling only on odd numbered days. Although the recruitment process may 
vary by site, potential participants will be approached by a member of the research staff and 
will be asked to review a copy of the IRB-approved informed consent form. The research 
staff will review the consent form and address any questions or concerns prior to obtaining 
written informed consent for PRIME participation. The research staff will also address any 
future questions or concerns that may occur. To insure lack of selection bias, a screening 
log of subjects who meet eligibility criteria, but decline consent, will be kept at the site. A de-
identified version of this list will be provided to the coordinating center on request.  
 
6. Potential Risks of Research Registry Participation: 
There are no risks of physical harm associated with participation in PRIME as this is an 
observational registry only and no treatment is added or dropped due to a patient’s 
participation in the registry.  Participation in PRIME does involve the potential risks of a 
breach of confidentiality of the medical record information and associated privacy of the 
participants. Such risks will be minimized by 1) removing direct participant identifiers (i.e., 
there will be no names, social security numbers, medical record numbers recorded); 2) 
placing recorded information on a secure server with limited access to information linking 
unique subject record numbers with direct participant identifiers; and 3) limiting access to 
the PRIME database to the appropriate IRB-approved staff at each site.  Each user at a site 
will have his or her own log-on and password to access the database.  Obtaining access to 
the database allows research staff the ability to enter patients’ clinical data and to view their 
site’s data.  Site users are unable to access or view data from other sites. 
. 
   
7. Potential Benefits of Research Registry Participation: 
There are no direct benefits associated with participation in PRIME. However, the use of 
information contained within PRIME for retrospective analyses may be of future benefit to 
patients with PVD.  Participants in PRIME will be informed of future research studies 
involving PVD for which they may be eligible if they so desire. 

 
 
 
 
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8. Costs and Payments: 
All costs associated with the implementation and maintenance of PRIME shall be supported 
by Metro Health through institutional support and unrestricted grants from industry. No costs 
will be incurred by PRIME participants. Patients will not be remunerated for their 
participation in PRIME.  Similarly, as this is a voluntary registry, sites will not be paid to 
participate in the registry. 
 
9. Addition of PRIME Registry Sites: 
Once the decision is made by the PRIME Steering Committee to add a new site, the 
Coordinating Center will communicate with that site to insure all regulatory documents are 
completed.  PRIME Registry members are required to have active IRB approval and a 
signed data use agreement to participate in PRIME.  Only after these documents are 
received by the Coordinating Center are users at each site issued log-ons and passwords 
for the database.  Patient consent requirements are determined by each site’s IRB.  IRB 
approval must be updated regularly based on the schedule determined by each institution’s 
review board.  Sites that have not maintained IRB approval may not continue to add patients 
to the registry until their IRB approval is obtained. 
 
In order to ensure data accuracy, periodic auditing of participating sites will be conducted.  
The PRIME Coordinating Center  will receive de-identified source documents for the first five 
patients enrolled at each new center; additionally, documentation for subsequent patients 
may be requested if deemed necessary by the reviewers.  Further adjudication may be 
performed at random intervals. 
 
10. Statistical Design: 
Coordinating Center statisticians combine data collected from all sites in aggregate 
tables.  Only aggregate data is used in analysis.  No identifiable data are used.   
 
Continuous data shall be expressed as means +/-standard deviations or medians (Q1-Q3) 
as appropriate.  Discrete data shall be expressed as counts and percentages.  Chi-squared, 
Fisher’s exact tests and student’s t-tests may be used as appropriate to determine statistical 
significance.  Linear and logistic regression and survival analysis may be applied to create 
statistical models. 
 
11. Protocol References: 
1. Shammas NW. Epidemiology, classification, and modifiable risk factors of 
peripheral arterial disease. Vasc Health Risk Manag 2007;3(2):229-34. 
2. Forbes JF, Adam DJ, Bell J, Fowkes FG, Gillespie I, Raab GM, et al. Bypass 
versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: Health-related 
quality of life outcomes, resource utilization, and cost-effectiveness analysis. J 
Vasc Surg 2010;51(5 Suppl):43S-51S. 
3. Ghaferi AA, Birkmeyer JD, Dimick JB. Variation in hospital mortality associated 
with inpatient surgery. N Engl J Med 2009;361(14):1368-75. 
4. Goodney PP, Travis LL, Nallamothu BK, Holman K, Suckow B, Henke PK, et al. 
Variation in the use of lower extremity vascular procedures for critical limb 
ischemia. Circ Cardiovasc Qual Outcomes 2012;5(1):94-102. 
5. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. 
Inter-Society Consensus for the Management of Peripheral Arterial Disease 
(TASC II). J Vasc Surg 2007;45 Suppl S:S5-67. 

 
 
 
 
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12. Database References: 
1. Creager MA, Belkin M, Bluth EI, Casey DE Jr, Chaturvedi S, Dake MD, et al.  
Key Data Elements and Definitions for Peripheral Atherosclerotic Vascular 
Disease.  J Am Coll Cardiol 2012;59(3):294-357. 
2. Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, et al.  
ACC/AHA 2005 Guidelines for the Management of Patients With Peripheral 
Arterial Disease (Lower Extremity, Renal, Mesenteric, and Abdominal Aortic).  
JACC 2006;47(6):1239-1312. 
3. Mehran R, Rao SV, Bhatt, DL, Gibson CM, Caixeta A, Eikelboom J, et al.  
Standardized Bleeding Definitions for Cardiovascular Clinical Trials.  Circulation 
AHA 2011;123:2736-2747 
4. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. 
Inter-Society Consensus for the Management of Peripheral Arterial Disease 
(TASC II). J Vasc Surg 2007;45 Suppl S:S5-67.