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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054636
Recruitment Status : Terminated (After data review of enrolled pts, it was determined that initial study objectives would not be met w/ continuation of enrollment)
First Posted : February 15, 2017
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Volcano Corporation

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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Short-term 2D Perfusion Angiography Pilot Study
Study Start Date : January 2017
Actual Primary Completion Date : February 14, 2019
Actual Study Completion Date : February 14, 2019



Primary Outcome Measures :
  1. Safety (Freedom from Major Adverse Device Effects) [ Time Frame: 30 days ]
    Freedom from Major Adverse Device Effects through 30 day visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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) )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054636


Locations
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United States, Florida
Miami Cardiac and Vascular Institute
Miami, Florida, United States, 33176
United States, Michigan
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, North Carolina
North Carolina Heart and Vascular
Raleigh, North Carolina, United States, 27607
United States, Ohio
University Hospitals
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Volcano Corporation
Investigators
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Principal Investigator: Jihad Mustapha, MD Metro Health Hospital
Principal Investigator: Larry J Diaz-Sandoval, MD Metro Health Hospital
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Responsible Party: Volcano Corporation
ClinicalTrials.gov Identifier: NCT03054636    
Other Study ID Numbers: 160201
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases