NCT02539303撤回1 期
In-vivo Demineralization of Calcific Peripheral Arterial Disease (PAD) Using Local Delivery of Yamani-15/5 Chemical Solution
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Feasibility
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention
Experimental
Infusion of Yamani-15/5 chemical solution.
干预措施: Yamani-15/5 chemical solution (Drug)
结局指标
主要结局
Feasibility
时间窗: Change from baseline
Percent of arterial lumen patency measured by angiography and compared to baseline.
次要结局
- 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)
研究者
Houssam Farres, M.D.
Dr. Houssam Farres
Mayo Clinic
相似试验
已完成
不适用
Pilot Medical Evaluation of the T50 TestCardiovascular DiseasesVascular CalcificationRenal FailureNCT03292029Fresenius Medical Care Deutschland GmbH776
终止
4 期
RELieving Increasing oEdema Due to Heart FailureHeart Failure，CongestiveNCT04142788NHS Greater Glasgow and Clyde19
Unknown
不适用
A Novel Method for Retrograde Intrarenal Surgery (RIRS)Kidney StoneNCT05202158Ankara Training and Research Hospital76
Unknown
1 期
Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary CirrhosisPrimary Biliary CirrhosisNCT01440309Robert Chunhua Zhao, MD, PhD20
进行中（未招募）
1 期
Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation TherapyHead and Neck CancerXerostomiaNCT05820711University of Wisconsin, Madison23