Short-term Perfusion Angiography Pilot Study (SPA) (SPA)

Short-term 2D Perfusion Angiography Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Peripheral Arterial Disease

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.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Miami Cardiac and Vascular Institute
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Metro Health Hospital
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Heart and Vascular
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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) )

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (Freedom from Major Adverse Device Effects)	Freedom from Major Adverse Device Effects through 30 day visit.	30 days

Collaborators and Investigators

• Sponsor: Volcano Corporation
• Investigators: Principal Investigator: Larry J Diaz-Sandoval, MD, Metro Health Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (ACTUAL): February 14, 2019
• Study Completion (ACTUAL): February 14, 2019

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (ACTUAL): February 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 160201