Endovascular Denervation in Patients With Peripheral Arterial Disease
Paraules clau
Resum
Descripció
Peripheral arterial disease(PAD) show insufficient blood supply of diseased limbs, which causes intermittent claudication of lower limbs, reduced skin temperature, pain, and chronic progressive disease that still produces ulcer or necrosis. Some clinical studies have shown Sympathetic overactivity in the lower arterial ischemic disease. The multi-electrode radiofrequency ablation system can significantly reduce the excitability of sympathetic nerve, restore the normal response of sympathetic nerve, relieve the pain and discomfort of patients, effectively improve the symptoms of lower limb ischemia, and improve the quality of life of patients.
Dates
| Darrera verificació: | 07/31/2019 |
| Primer enviat: | 08/15/2019 |
| Inscripció estimada enviada: | 08/15/2019 |
| Publicat per primera vegada: | 08/18/2019 |
| Última actualització enviada: | 08/15/2019 |
| Publicació de l'última actualització: | 08/18/2019 |
| Data d'inici de l'estudi real: | 08/12/2019 |
| Data estimada de finalització primària: | 08/31/2022 |
| Data estimada de finalització de l’estudi: | 08/31/2023 |
Condició o malaltia
Intervenció / tractament
Device: endovascular denervation
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: endovascular denervation endovascular denervation | Device: endovascular denervation multi-electrode catheter-based endovascular denervation |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: - 18 to 75 years - Patients with established PAD with Rutherford Grade2-6 Exclusion Criteria: - pregnant or intent to become pregnant - Orthostatic hypotension - acute or severe systemic infection - uncorrected coagulation dysfunction - renal dysfunction - Patients that have allergy to contrast agent and nitinol - Myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion - Cerebrovascular accidents and alimentary tract hemorrhage within 3 months before inclusion - participants who are not suitable to be enrolled into the study assessed bythe researchers |
Resultat
Mesures de resultats primaris
1. Ischemia relief [from baseline to 1 months after procedure]
Mesures de resultats secundaris
1. Ischemia relief [from baseline to 3months after procedure]
2. pain relief [from baseline to 3 months after procedure]
