Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients (Extended Poly Tetra Fluoro Ethylene) (ePTFE)
Primary Purpose
End Stage Renal Disease
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Double vein cuffed ePTFE graft both at the inflow and outflow ends
single vein cuffed eTFE graft both at the inflow and outflow ends
ePTFE graft without any cuff
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring ESRD, ePTFE, neointemal hyperplasia
Eligibility Criteria
Inclusion Criteria:
- Patients with end stage renal diseases and GFR less than 30
- By clinical examination in ability to palpate distal or proximal upper limb veins 3. By duplex examination the diameter of cephalic or basilic veins are less than 3 mm or reported to be incompressible 4. Patients with previous history of failed attempts of autogenous vein creation 5. Patients with border line cephalic or basilica vein (3mm) and on intraoperative the vein diameter appears to be unsuitable (less than 3 mm).
Exclusion Criteria:
- All patients with palpable suitable forearm or arm veins
- Patients with baseline blood pressure less than 110/70
- Brachial artery of diameter less than 4 mm
- Patients with ligated brachial artery
- Patients with history of central vein stenosis
- Patients with immunodeficiency states
Sites / Locations
- Mansoura faculty of medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Double vein cuff PTFE graft both at the inflow and outflow ends
Single vein cuffed PTFE graft at the outflow end
PTFE graft without vein cuff will be used
Outcomes
Primary Outcome Measures
primary patency
comparing primary patency between the double cuffed, single cuffed and non cuffed ePTFE graft primary patency means how long will the graft be patent after the first intervention
Secondary Outcome Measures
secondary patency
comparing secondary patency between the double cuffed, single cuffed and non cuffed ePTFE graft secondary patency means how long will the graft be patent after thormobectomy to a thrombosed graft
Full Information
NCT ID
NCT03405233
First Posted
January 12, 2018
Last Updated
February 12, 2018
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT03405233
Brief Title
Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients (Extended Poly Tetra Fluoro Ethylene)
Acronym
ePTFE
Official Title
Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
this randomized controlled trial will compare the double vein cuffed synthetic arteriovenous graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long-term patency of each modality
Detailed Description
End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years.End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years. Haemodialysis (HD) is a lifeline therapy for patients with ESRD. A proportion of hemodialysis patients exhaust all options for permanent vascular access (fistula or graft) in both upper extremities.ePTFE grafts are easily subjected to graft outflow tract intimal hyperplasia, which may lead to graft outlet stenosis and graft thrombosis after a certain period of usage. The commonest cause of PTFE graft failure is intimal hyperplasia (IH) at the venous anastomoses. our study aims to evaluate the influence of double cuffed ePTFE grafts with autologous vein cuffs on the long-term patency of dialysis access, and compare the clinical patency and the complications occurring with the usage of the double cuffed graft to that with standard non cuffed grafts in chronic renal hemodialysis therapy.
this randomized controlled trial will compare the double vein cuffed synthetic arteriovenous graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long term patency of each modality
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
ESRD, ePTFE, neointemal hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
the patients do not know which group will they belong the duplex operator will not know the details of operative data
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Double vein cuff PTFE graft both at the inflow and outflow ends
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Single vein cuffed PTFE graft at the outflow end
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
PTFE graft without vein cuff will be used
Intervention Type
Procedure
Intervention Name(s)
Double vein cuffed ePTFE graft both at the inflow and outflow ends
Intervention Description
Vein cuff is obtained from a segment of one of the arm veins (cephalic or basilica) after incising it longitudinally and wrapped around both ends of PTFE Graft
Intervention Type
Procedure
Intervention Name(s)
single vein cuffed eTFE graft both at the inflow and outflow ends
Intervention Description
Vein cuff is obtained from a segment of one of the arm veins (cephalic or basilica) after incising it longitudinally and wrapped around the venous end of PTFE Graft
Intervention Type
Procedure
Intervention Name(s)
ePTFE graft without any cuff
Intervention Description
anastmosis between arterial and venous side usinf non cuffed ePTFE graft
Primary Outcome Measure Information:
Title
primary patency
Description
comparing primary patency between the double cuffed, single cuffed and non cuffed ePTFE graft primary patency means how long will the graft be patent after the first intervention
Time Frame
2 years for each patient after the operation
Secondary Outcome Measure Information:
Title
secondary patency
Description
comparing secondary patency between the double cuffed, single cuffed and non cuffed ePTFE graft secondary patency means how long will the graft be patent after thormobectomy to a thrombosed graft
Time Frame
2 years after restoration of patency
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with end stage renal diseases and GFR less than 30
By clinical examination in ability to palpate distal or proximal upper limb veins 3. By duplex examination the diameter of cephalic or basilic veins are less than 3 mm or reported to be incompressible 4. Patients with previous history of failed attempts of autogenous vein creation 5. Patients with border line cephalic or basilica vein (3mm) and on intraoperative the vein diameter appears to be unsuitable (less than 3 mm).
Exclusion Criteria:
All patients with palpable suitable forearm or arm veins
Patients with baseline blood pressure less than 110/70
Brachial artery of diameter less than 4 mm
Patients with ligated brachial artery
Patients with history of central vein stenosis
Patients with immunodeficiency states
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hussein mohamed Abdelaziz, PHD
Phone
+201002421140
Ext
+2
Email
menhag@mans.edu.eg
Facility Information:
Facility Name
Mansoura faculty of medicine
City
Mansourah
State/Province
Delta
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelaziz Mohamed Hussien, Assistant professor
Phone
01002421140
Ext
+2
Email
menhag@mans.edu.eg
First Name & Middle Initial & Last Name & Degree
Amr Mohamed Elshafei, Assist lecturer
Phone
01211336635
Ext
+2
Email
amrelshafie@mans.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16754802
Citation
Cheng C, Tempel D, van Haperen R, van der Baan A, Grosveld F, Daemen MJ, Krams R, de Crom R. Atherosclerotic lesion size and vulnerability are determined by patterns of fluid shear stress. Circulation. 2006 Jun 13;113(23):2744-53. doi: 10.1161/CIRCULATIONAHA.105.590018. Epub 2006 Jun 5.
Results Reference
background
PubMed Identifier
26787576
Citation
Ghonemy TA, Farag SE, Soliman SA, El-okely A, El-hendy Y. Epidemiology and risk factors of chronic kidney disease in the El-Sharkia Governorate, Egypt. Saudi J Kidney Dis Transpl. 2016 Jan;27(1):111-7. doi: 10.4103/1319-2442.174137.
Results Reference
background
PubMed Identifier
23371958
Citation
Ong S, Barker-Finkel J, Allon M. Long-term outcomes of arteriovenous thigh grafts in hemodialysis patients: a comparison with tunneled dialysis catheters. Clin J Am Soc Nephrol. 2013 May;8(5):804-9. doi: 10.2215/CJN.09240912. Epub 2013 Jan 31.
Results Reference
background
PubMed Identifier
18343971
Citation
Tsoulfas G, Hertl M, Ko DS, Elias N, Delmonico FL, Romano L, Fernandes I, Schoenfeld D, Kawai T. Long-term outcome of a cuffed expanded PTFE graft for hemodialysis vascular access. World J Surg. 2008 Aug;32(8):1827-31. doi: 10.1007/s00268-008-9514-z.
Results Reference
background
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Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients (Extended Poly Tetra Fluoro Ethylene)
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