Peripheral Arterial DiseaseSPANCT03054636
Short-term Perfusion Angiography Pilot Study (SPA)
An observational study of Peripheral Arterial Disease, run by Volcano Corporation at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 38 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2017to 14 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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) )
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University Hospitals
Cleveland, Ohio, 44106
Miami Cardiac and Vascular Institute
Miami, Florida, 33176
North Carolina Heart and Vascular
Raleigh, North Carolina, 27607
Metro Health Hospital
Wyoming, Michigan, 49519
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Freedom from Major Adverse Device Effects)
Freedom from Major Adverse Device Effects through 30 day visit.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startJan 2017
- Primary completion14 Feb 2019
- Study completion14 Feb 2019
Why it stopped: After data review of enrolled pts, it was determined that initial study objectives would not be met w/ continuation of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volcano Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jihad Mustapha, MD, Principal investigator, Metro Health HospitalLarry J Diaz-Sandoval, MD, Principal investigator, Metro Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054636
- Sponsor's protocol ID
- 160201
- Acronym
- SPA
- Status last verified
- Jun 2020
- First submitted
- 13 Feb 2017
- Last updated
- 12 Jun 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term 2D Perfusion Angiography Pilot Study
- ClinicalTrials.gov ID
- NCT03054636
- Acronym / sponsor ID
- SPA / 160201
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: After data review of enrolled pts, it was determined that initial study objectives would not be met w/ continuation of enrollment
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Volcano CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety (Freedom from Major Adverse Device Effects)
Time frame: 30 days
Freedom from Major Adverse Device Effects through 30 day visit.
Results and safety
The study was stopped early (reason given: After data review of enrolled pts, it was determined that initial study objectives would not be met w/ continuation of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jihad Mustapha, MD principal investigator
Metro Health Hospital
Larry J Diaz-Sandoval, MD principal investigator
Metro Health Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Volcano Corporation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: After data review of enrolled pts, it was determined that initial study objectives would not be met w/ continuation of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Freedom from Major Adverse Device Effects) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.