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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

Tracking Information
First Submitted Date February 13, 2017
First Posted Date February 15, 2017
Last Update Posted Date June 12, 2020
Study Start Date January 2017
Actual Primary Completion Date February 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 14, 2017)
Safety (Freedom from Major Adverse Device Effects) [ Time Frame: 30 days ]
Freedom from Major Adverse Device Effects through 30 day visit.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Short-term Perfusion Angiography Pilot Study (SPA)
Official Title Short-term 2D Perfusion Angiography Pilot 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Peripheral Arterial Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 10, 2020)
38
Original Estimated Enrollment
 (submitted: February 14, 2017)
110
Actual Study Completion Date February 14, 2019
Actual Primary Completion Date February 14, 2019   (Final data collection date for primary outcome measure)
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) )
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03054636
Other Study ID Numbers 160201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Volcano Corporation
Study Sponsor Volcano Corporation
Collaborators Not Provided
Investigators
Principal Investigator: Jihad Mustapha, MD Metro Health Hospital
Principal Investigator: Larry J Diaz-Sandoval, MD Metro Health Hospital
PRS Account Volcano Corporation
Verification Date June 2020