Short-term Perfusion Angiography Pilot Study (SPA) | NCT03054636

Studies
Short-term Perfusion Angiography Pilot Study (SPA)

NCT03054636

Sponsor

Volcano Corporation

Status

Terminated

Last Update Posted

Jun 12, 2020Actual

Enrollment

38Actual

Phase

Not provided

Conditions

Peripheral Arterial Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

After data review of enrolled pts, it was determined that initial study objectives would not be met w/ continuation of enrollment

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Feb 14, 2019Actual

Completion Date

Feb 14, 2019Actual

First Submitted Date

Feb 13, 2017

First Submission Date that Met QC Criteria

Feb 14, 2017

First Posted Date

Feb 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2020

Last Update Posted Date

Jun 12, 2020Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:
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:

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
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) )

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Jihad Mustapha, MD	Metro Health Hospital	Principal Investigator
Larry J Diaz-Sandoval, MD	Metro Health Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Miami Cardiac and Vascular Institute		Miami	Florida	33176	United States
Metro Health Hospital

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases