Delivery of Yamani-15/5 Chemical Solution for PAD | NCT02539303

Studies
Delivery of Yamani-15/5 Chemical Solution for PAD

NCT02539303

Sponsor

Mayo Clinic

Status

Withdrawn

Last Update Posted

Aug 4, 2022Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Peripheral Arterial Disease

Interventions

Yamani-15/5 chemical solution

Countries

Not provided

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to enroll subjects

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Aug 2022Estimated

Completion Date

Aug 2023Estimated

First Submitted Date

Aug 27, 2015

First Submission Date that Met QC Criteria

Sep 2, 2015

First Posted Date

Sep 3, 2015Estimated

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

Aug 2, 2022

Last Update Posted Date

Aug 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Infusion of Yamani-15/5 chemical solution.	Drug: Yamani-15/5 chemical solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Yamani-15/5 chemical solution	Drug	A 20 ml of Yamani-15/5 will be directly infused into the diseased (calcific) arterial distribution.	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility	Percent of arterial lumen patency measured by angiography and compared to baseline.	Change from baseline

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Houssam Farres, MD	Mayo Clinic	Principal Investigator

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided