Alprostadil as an Adjuvant Therapy With Indirect Angiosomal Revascularization in Critical Limb Ischemia.

NCT04312555 | Unknown Phase 4

• 1 other identifier: Alprostadil with CLI
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Critical Limb Ischemia

Keywords

CLI

Outcome Measures

Primary Outcomes (2)

• Patency

  Maintaining vessel patency without restenosis or need for re-intervention

  3 months

• Major Adverse Limb Events (MALE)

  repeated endovascular therapy, surgical revision, or major amputation during follow up period

  3 months

Interventions

Alprostadil DRUG

Alprostadil intravenous administration. (0.5 mg/1ml of Alprostadil + 49cm saline 0.9%) and 4 cm direct intravenously / 8 hours

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject ≥ 40 years.
• Subject with chronic limb ischemia \[Rutherford classification 4, 5 \& 6\].
• Subject failed to direct revascularization.
• Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
• Subject has provided written informed consent.

You may not qualify if:

• Subject's age less than 40.
• Imminent or foreseeable amputation
• Subject already had a major amputation on the affected extremity
• Subject has emergent ischemic lesion \[such as gas forming infection\].
• Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment.
• Subject has a known hypersensitivity or contraindication to Alprostadil.
• Subject is not in the position to be primarily revascularized or refuses surgery.
• Acute ischemia and peripheral vascular disorders of inflammatory or immunologic origin
• Neuropathic or venous ulcers
• Already using vasoactive medication or prostaglandins

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 9540428 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.

  PMID: 10658439 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.

  PMID: 25241316 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.

  PMID: 22817860 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.

  PMID: 22051875 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.

  PMID: 23219512 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.

  PMID: 21969804 BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Alprostadil

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Ashraf Elnaggar, Dr

  Assiut University

  PRINCIPAL INVESTIGATOR

• Hassan Bakr El-Badawy, Prof

  Assiut University

  STUDY CHAIR

• Mohamed Elsagheer Elhewwy, Prof

  Al-Azhar University

  STUDY DIRECTOR

Central Study Contacts

Seif Eleslam Tawfik, Resident

CONTACT

+201008011018; dr.seifalkadi@yahoo.com

Ashraf Elnaggar, MD

CONTACT

01005212168; Ashrafnagar@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at Vascular & Endovascular surgery department

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share