drugset / Trial / NCT04312555
Alprostadil as an Adjuvant Therapy With Indirect Angiosomal Revascularization in Critical Limb Ischemia.
NaSingle-groupOpen-labelTreatment
Summary
The aim of this study is to assess the efficacy of Alprostadil (Prostaglandin E2) as adjuvant therapy after failure of direct but indirect angiosomal revascularization in patients with critical limb ischemia.
Timeline
- Start
- 2020-04-01
- Primary completion
- 2021-04-01
- Completion
- 2021-10-01
Publications
- Background Kroger K, Hwang I, Rudofsky G. Recanalization of chronic peripheral arterial occlusions by alternating intra-arterial rt-PA and PGE1. Vasa. 1998 Feb;27(1):20-3.
- Background Bucci M, Iacobitti P, Laurora G, Cesarone MR. [Analysis of costs and results of prostaglandin (PGE1 alpha-cyclodestrin) therapy of peripheral arterial diseases]. Minerva Cardioangiol. 1998 Oct;46(10 Suppl 1):9-15. Italian.
- Background Palena LM, Garcia LF, Brigato C, Sultato E, Candeo A, Baccaglini T, Manzi M. Angiosomes: how do they affect my treatment? Tech Vasc Interv Radiol. 2014 Sep;17(3):155-69. doi: 10.1053/j.tvir.2014.08.004.
- Background Neville RF, Sidawy AN. Surgical bypass: when is it best and do angiosomes play a role? Semin Vasc Surg. 2012 Jun;25(2):102-7. doi: 10.1053/j.semvascsurg.2012.04.001.
- Background Iida O, Soga Y, Hirano K, Kawasaki D, Suzuki K, Miyashita Y, Terashi H, Uematsu M. Long-term results of direct and indirect endovascular revascularization based on the angiosome concept in patients with critical limb ischemia presenting with isolated below-the-knee lesions. J Vasc Surg. 2012 Feb;55(2):363-370.e5. doi: 10.1016/j.jvs.2011.08.014. Epub 2011 Nov 1.
- Background Soderstrom M, Alback A, Biancari F, Lappalainen K, Lepantalo M, Venermo M. Angiosome-targeted infrapopliteal endovascular revascularization for treatment of diabetic foot ulcers. J Vasc Surg. 2013 Feb;57(2):427-35. doi: 10.1016/j.jvs.2012.07.057. Epub 2012 Dec 7.
- Background Alexandrescu V, Hubermont G. Primary infragenicular angioplasty for diabetic neuroischemic foot ulcers following the angiosome distribution: a new paradigm for the vascular interventionist? Diabetes Metab Syndr Obes. 2011;4:327-36. doi: 10.2147/DMSO.S23471. Epub 2011 Aug 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alprostadil | Unknown | 0.5 mg | Intravenous |