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NCT02539303 Clinical Trial

Delivery of Yamani-15/5 Chemical Solution for PAD

Peripheral Arterial Disease Clinical Trial

Official title:
In-vivo Demineralization of Calcific Peripheral Arterial Disease (PAD) Using Local Delivery of Yamani-15/5 Chemical Solution

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02539303
Other study ID # 15-001279
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date August 2015
Est. completion date August 2023

Study information
Verified date August 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 2023
Est. primary completion date August 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Yamani-15/5 chemical solution
A 20 ml of Yamani-15/5 will be directly infused into the diseased (calcific) arterial distribution.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility Percent of arterial lumen patency measured by angiography and compared to baseline. Change from baseline
Secondary 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. Compared to baseline
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