Clinical Testing Study in Peripheral Arterial Disease

NCT05243992 | Unknown

• 1 other identifier: CTS-PAD 0133633 Ver00004.5
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Purpose of the Clinical Testing Study in Peripheral Arterial Disease (CTS-PAD) study is to compare measurement outcomes between conventional Ankle-Brachial Index test for Peripheral Arterial Disease with a new imaging technology from which the same data can be derived, in a series of patients referred to Vascular Surgery Clinics at the University of Rochester for suspected peripheral arterial disease.

Conditions

Peripheral Arterial Disease

Keywords

tissue perfusion; tissue hypoxemia

Outcome Measures

Primary Outcomes (1)

• Ratio Comparison

  Comparison of the cABI systolic BP threshold ratio vs. the CTS-PAD perfusion ratio

  ten (10) minutes

Secondary Outcomes (2)

• Clinical status impact on CTS-PAD outcomes

  ten (10) minutes

• Device use and performance

  ten (10) minutes

Interventions

CTS-PAD device imaging OTHER

Participants in the CTS-PAD Study will undergo a conventional ABI (cABI) evaluation, followed by the non-contact imaging evaluation with the CTS-PAD device. The supplemental CTS-PAD testing will add approximately ten (10) minutes to the overall evaluation time.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient population: The screening population for this study will be adults seen in vascular clinic referred for peripheral arterial disease. The U of R Vascular Clinic performs \> 40-50 cABI studies / month, and their clinic population has patients with severe PVD at presentation, extensive cardiovascular risk factors that affect the sensitivity of cABI testing, and heterogenous age, race and gender characteristics. An analysis of the patient population demographics suggests that the gender distribution will be 60% male and 40% female in this study. Gender-based enrollment restrictions include women who are pregnant or who might be pregnant, since the imaging technology has not been tested in this sub-population. There are no enrollment restrictions based on race and/or ethnic origin. Overall enrollment is anticipated to be 60% Caucasian, 20% African-American, 6% Hispanic, non-white, 1% Asian, and 1% Other.

You may qualify if:

• patients who meet the clinical, symptomatic and or the disease complexity criteria for cABI testing
• age \> 21 years
• intact bilateral upper and lower extremities

You may not qualify if:

• patients who are not considered candidates for the cABI test
• patients \< 21 years
• women who might be pregnant or who are pregnant
• patients who are not considered eligible by the Attending Vascular Surgical team in clinic for medical reasons
• patients who are unable to undergo the cABI study
• patients who are unable to complete the precedent cABI study
• patients without intact bilateral upper and lower extremities
• patients with lower extremity edema or associated vascular disease where performance of the precedent cABI test would be difficult or unlikely to yield reliable data
• asymptomatic patients without complex disease characteristics, since they would not be referred for cABI testing

Sponsors & Collaborators

• Perfusio Corp.: lead
• University of Rochester: collaborator

Related Links

• Sponsor Web site

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Thomas B Ferguson, MD

  Perfusio Corp.

  STUDY DIRECTOR

Central Study Contacts

Thomas B Ferguson, MD

CONTACT

5044739511; bruce.ferguson@perfusio.com

Emma McCarter

CONTACT

252-656-0404; emma.mccarter@perfusio.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 17, 2022
• Study Start: March 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share