Clinical Trials Logo
  1. Home
  2. Peripheral Arterial Disease
  3. NCT02539303
  4. Details
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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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
See also
  Status Clinical Trial Phase
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Active, not recruiting NCT03987061 - MOTIV Bioresorbable Scaffold in BTK Artery Disease N/A
Recruiting NCT03506633 - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients N/A
Active, not recruiting NCT03506646 - Dietary Nitrate Supplementation and Thermoregulation N/A
Active, not recruiting NCT04677725 - NEtwork to Control ATherothrombosis (NEAT Registry)
Recruiting NCT05961943 - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients N/A
Recruiting NCT06047002 - Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Completed NCT03185052 - Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach N/A
Recruiting NCT05992896 - A Study of Loco-Regional Liposomal Bupivacaine Injection Phase 4
Completed NCT04635501 - AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial N/A
Recruiting NCT04584632 - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery N/A
Withdrawn NCT03994185 - The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease N/A
Withdrawn NCT03538392 - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Recruiting NCT02915796 - Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty Phase 1
Active, not recruiting NCT02900924 - Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Completed NCT02901847 - To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities. N/A
Not yet recruiting NCT02455726 - Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease N/A
Withdrawn NCT02126540 - Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries N/A
Not yet recruiting NCT02387450 - Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication Phase 2/Phase 3
Completed NCT02384980 - Saving Life and Limb: FES for the Elderly With PAD Phase 1

External Links