Delivery of Yamani-15/5 Chemical Solution for PAD
Cuvinte cheie
Abstract
Datele
| Ultima verificare: | 07/31/2019 |
| Primul depus: | 08/26/2015 |
| Inscriere estimată trimisă: | 09/01/2015 |
| Prima postare: | 09/02/2015 |
| Ultima actualizare trimisă: | 08/11/2019 |
| Ultima actualizare postată: | 08/13/2019 |
| Data actuală de începere a studiului: | 07/31/2015 |
| Data estimată de finalizare primară: | 07/31/2020 |
| Data estimată de finalizare a studiului: | 07/31/2020 |
Stare sau boală
Intervenție / tratament
Drug: Intervention
Fază
Grupuri de brațe
| Braţ | Intervenție / tratament |
|---|---|
| Experimental: Intervention Infusion of Yamani-15/5 chemical solution. | Drug: Intervention A 20 ml of Yamani-15/5 will be directly infused into the diseased (calcific) arterial distribution. |
Criterii de eligibilitate
| Vârste eligibile pentru studiu | 18 Years La 18 Years |
| Sexe eligibile pentru studiu | All |
| Acceptă voluntari sănătoși | da |
| Criterii | 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. |
Rezultat
Măsuri de rezultate primare
1. Feasibility [Change from baseline]
Măsuri de rezultate secundare
1. 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]
