Study Stopped
After data review of enrolled pts, it was determined that initial study objectives would not be met w/ continuation of enrollment
Short-term Perfusion Angiography Pilot Study (SPA)
SPA
Short-term 2D Perfusion Angiography Pilot Study
1 other identifier
observational
38
1 country
4
Brief Summary
The Short term Perfusion Angiography (SPA) study is designed to collect 2D Perfusion data from Critical Limb Ischemia (CLI) endovascular (interventional) procedures for information on device performance in a real-world setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2017
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 13, 2017
CompletedFirst Posted
Study publicly available on registry
February 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2019
CompletedJune 12, 2020
June 1, 2020
2.1 years
February 13, 2017
June 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Safety (Freedom from Major Adverse Device Effects)
Freedom from Major Adverse Device Effects through 30 day visit.
30 days
Eligibility Criteria
Approximately 132 patients with critical limb ischemia (Rutherford classification 4, 5 or 6) considered candidates for a diagnostic angiogram and likely endovascular intervention expected to be enrolled into the SPA Study
You may qualify if:
- Subject is ≥ 18 years of age.
- Subject or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent
- Subject has appropriate femoral arterial access
- Subject presents with a Rutherford classification of 4 to 6.
- Planned DSA with endovascular intervention below the knee on one or both limbs. This may include patients who undergo:
- Above the knee (ATK) and below the knee (BTK) intervention during the same procedure.
- Only BTK intervention.
- ATK intervention with staged future BTK intervention within 6 weeks of the initial procedure.
You may not qualify if:
- Subjects whose ATK intervention is limited to only the common femoral or iliac arteries
- Subject is unwilling or unable to comply with the protocol including all follow-up visits
- Subject with active atrial fibrillation at time of procedure
- Critical limb ischemia due to acute arterial occlusion.
- Subject with documented ejection fraction \< 40% and/or prolonged bradycardia (\< 60 beats per minute)
- Inability to collect toe pressure on index limb from subject
- Subjects with history of or known reaction or sensitivity to contrast agent that cannot be pre-medicated or any other condition that precludes an endovascular intervention and DSA
- Female subject of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to enrollment), or plans a pregnancy during study period,
- Subject life expectancy \< 3 months,
- Subject is participating in a potentially confounding device or drug clinical trial that interferes with this study
- Investigator considers subject to be a poor candidate for the study or believes that the patient may compromise the study, e.g., concomitant conditions (reasons will be documented) )
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Miami Cardiac and Vascular Institute
Miami, Florida, 33176, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
North Carolina Heart and Vascular
Raleigh, North Carolina, 27607, United States
University Hospitals
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jihad Mustapha, MD
Metro Health Hospital
- PRINCIPAL INVESTIGATOR
Larry J Diaz-Sandoval, MD
Metro Health Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2017
First Posted
February 15, 2017
Study Start
January 1, 2017
Primary Completion
February 14, 2019
Study Completion
February 14, 2019
Last Updated
June 12, 2020
Record last verified: 2020-06