Delivery of Yamani-15/5 Chemical Solution for PAD

Sponsor

Mayo Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02539303

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Drug: Yamani-15/5 chemical solution	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intervention

Infusion of Yamani-15/5 chemical solution.

Drug: Yamani-15/5 chemical solution

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

Outcome Measures

Primary Outcome Measures

Feasibility [Change from baseline]
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. [Compared to baseline]
Number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Houssam Farres, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Houssam Farres, M.D., Dr. Houssam Farres, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT02539303

Other Study ID Numbers:

15-001279

First Posted:

Sep 3, 2015

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Arterial Disease

Peripheral Vascular Diseases

Study Results

No Results Posted as of Aug 4, 2022