Clinical trial NCT03054636: Short-term Perfusion Angiography Pilot Study (SPA)
Official title: Short-term 2D Perfusion Angiography Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peripheral Arterial Disease
Lead sponsor: Volcano Corporation
Sponsor class: INDUSTRY
First posted: 2017-02-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Detailed description: This clinical study is designed to collect pre and post procedural imaging data using 2D Perfusion (2DP) software in patients receiving an endovascular intervention.

Eligibility criteria: Inclusion Criteria:

1. Subject is ≥ 18 years of age.
2. Subject or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent
3. Subject has appropriate femoral arterial access
4. Subject presents with a Rutherford classification of 4 to 6.
5. Planned DSA with endovascular intervention below the knee on one or both limbs. This may include patients who undergo:

   1. Above the knee (ATK) and below the knee (BTK) intervention during the same procedure.
   2. Only BTK intervention.
   3. ATK intervention with staged future BTK intervention within 6 weeks of the initial procedure.

Exclusion Criteria:

1. Subjects whose ATK intervention is limited to only the common femoral or iliac arteries
2. Subject is unwilling or unable to comply with the protocol including all follow-up visits
3. Subject with active atrial fibrillation at time of procedure
4. Critical limb ischemia due to acute arterial occlusion.
5. Subject with documented ejection fraction \< 40% and/or prolonged bradycardia (\< 60 beats per minute)
6. Inability to collect toe pressure on index limb from subject
7. 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
8. 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,
9. Subject life expectancy \< 3 months,
10. Subject is participating in a potentially confounding device or drug clinical trial that interferes with this study
11. 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) )

Primary outcomes:
measure: Safety (Freedom from Major Adverse Device Effects)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Cardiac and Vascular Institute
state: Florida
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Raleigh
country: United States
facility: North Carolina Heart and Vascular
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: Metro Health Hospital
name: Jihad Mustapha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Metro Health Hospital
name: Larry J Diaz-Sandoval, MD
role: PRINCIPAL_INVESTIGATOR
References: