Back to resultsDelivery of Yamani-15/5 Chemical Solution for PAD
Primary Purpose
Peripheral Arterial Disease
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Yamani-15/5 chemical solution
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
Subject has severe calcific PAD who have been deemed to have unreconstructable arterial disease and who have already been scheduled to undergo limb amputation (below knee or above knee amputation).
Exclusion:
- Patients who will be undergoing amputation of the limb because of infection, osteomyelitis or cancer.
- Patients with chronic kidney disease stage V (unless on dialysis).
- Patients with liver cirrhosis.
- Patients with history of deep vein thrombosis or pulmonary embolization in the last 3 months.
- Patients with history of stroke in the last 3 months.
- Patients with unstable angina or history of myocardial infarction in the last 3 months.
- Patients with sepsis, respiratory failure, hypovolemic shock or cardiogenic shock.
- Women who are pregnant or nursing.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Infusion of Yamani-15/5 chemical solution.
Outcomes
Primary Outcome Measures
Feasibility
Percent of arterial lumen patency measured by angiography and compared to baseline.
Secondary Outcome Measures
Safety as measured by the number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0.
Number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02539303
Brief Title
Delivery of Yamani-15/5 Chemical Solution for PAD
Official Title
In-vivo Demineralization of Calcific Peripheral Arterial Disease (PAD) Using Local Delivery of Yamani-15/5 Chemical Solution
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to enroll subjects
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a feasibility pilot study to evaluate the impact of local delivery of Yamani-15/5 (combination of L-Lactic acid 15% and D-Gluconic acid 5%) on vascular calcification of lower extremities in patients with severe peripheral arterial disease (PAD) who were deemed to have unreconstructable arterial disease and who have already been scheduled to undergo limb amputation (below knee or above knee amputation).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Infusion of Yamani-15/5 chemical solution.
Intervention Type
Drug
Intervention Name(s)
Yamani-15/5 chemical solution
Intervention Description
A 20 ml of Yamani-15/5 will be directly infused into the diseased (calcific) arterial distribution.
Primary Outcome Measure Information:
Title
Feasibility
Description
Percent of arterial lumen patency measured by angiography and compared to baseline.
Time Frame
Change from baseline
Secondary Outcome Measure Information:
Title
Safety as measured by the number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0.
Description
Number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0.
Time Frame
Compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subject has severe calcific PAD who have been deemed to have unreconstructable arterial disease and who have already been scheduled to undergo limb amputation (below knee or above knee amputation).
Exclusion:
Patients who will be undergoing amputation of the limb because of infection, osteomyelitis or cancer.
Patients with chronic kidney disease stage V (unless on dialysis).
Patients with liver cirrhosis.
Patients with history of deep vein thrombosis or pulmonary embolization in the last 3 months.
Patients with history of stroke in the last 3 months.
Patients with unstable angina or history of myocardial infarction in the last 3 months.
Patients with sepsis, respiratory failure, hypovolemic shock or cardiogenic shock.
Women who are pregnant or nursing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Houssam Farres, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Delivery of Yamani-15/5 Chemical Solution for PAD
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