End Stage Renal DiseaseePTFENCT03405233
Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients (Extended Poly Tetra Fluoro Ethylene)
A study testing Double vein cuffed ePTFE graft both at the inflow and outflow ends, single vein cuffed eTFE graft both at the inflow and outflow ends and ePTFE graft without any cuff in people with End Stage Renal Disease, run by Mansoura University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Double vein cuffed ePTFE graft both at the inflow and outflow ends, single vein cuffed eTFE graft both at the inflow and outflow ends and ePTFE graft without any cuff
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura faculty of medicine
Al Mansurah, Delta, 35516
Abdelaziz Mohamed Hussien, Assistant professor, 01002421140 ext. +2, menhag@mans.edu.eg
Amr Mohamed Elshafei, Assist lecturer, 01211336635 ext. +2, amrelshafie@mans.edu.eg
About this study
Official title: Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients: a Randomized Controlled Trial
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
Read the 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
- Conditions
- End Stage Renal Disease
- Being tested
- 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
- Keywords
- ESRD, ePTFE, neointemal hyperplasia
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double vein cuffed ePTFE graft both at the inflow and outflow endsProcedure or surgery
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
single vein cuffed eTFE graft both at the inflow and outflow endsProcedure or surgery
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
ePTFE graft without any cuffProcedure or surgery
anastmosis between arterial and venous side usinf non cuffed ePTFE graft
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Double vein cuff PTFE graft both at the inflow and outflow ends Receives: Procedure: Double vein cuffed ePTFE graft both at the inflow and outflow ends |
| Group B | Active comparator | Single vein cuffed PTFE graft at the outflow end Receives: Procedure: single vein cuffed eTFE graft both at the inflow and outflow ends |
| Group C | Active comparator | PTFE graft without vein cuff will be used Receives: Procedure: ePTFE graft without any cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years for each patient after the operation
Secondary outcomes (1)
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
Measured: 2 years after restoration of patency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Feb 2018
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Elshafie, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405233
- Sponsor's protocol ID
- R.18.01.6.R1
- Acronym
- ePTFE
- Status last verified
- Feb 2018
- First submitted
- 12 Jan 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16754802Ghonemy 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.
PubMed 26787576Ong 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.
PubMed 23371958Tsoulfas 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.
PubMed 18343971
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03405233
- Acronym / sponsor ID
- ePTFE / R.18.01.6.R1
- Conditions
- End Stage Renal Disease
- Keywords
- ESRD, ePTFE, neointemal hyperplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Double vein cuffed ePTFE graft both at the inflow and outflow endsDouble vein cuff PTFE graft both at the inflow and outflow ends |
| Group B | Active comparator | Procedure: single vein cuffed eTFE graft both at the inflow and outflow endsSingle vein cuffed PTFE graft at the outflow end |
| Group C | Active comparator | Procedure: ePTFE graft without any cuffPTFE graft without vein cuff will be used |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double vein cuffed ePTFE graft both at the inflow and outflow endsVein 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 | Procedure or surgery | Group A |
| single vein cuffed eTFE graft both at the inflow and outflow endsVein 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 | Procedure or surgery | Group B |
| ePTFE graft without any cuffanastmosis between arterial and venous side usinf non cuffed ePTFE graft | Procedure or surgery | Group C |
Primary outcome
primary patency
Time frame: 2 years for each patient after the operation
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
1 secondary outcome
secondary patency
Time frame: 2 years after restoration of patency
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Background: PubMed 16754802Cheng 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.
- Background: PubMed 26787576Ghonemy 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.
- Background: PubMed 23371958Ong 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.
- Background: PubMed 18343971Tsoulfas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double vein cuffed ePTFE graft both at the inflow and outflow ends, single vein cuffed eTFE graft both at the inflow and outflow ends and ePTFE graft without any cuff in people with End Stage Renal Disease, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hussein mohamed Abdelaziz, PHD (+201002421140 ext. +2, menhag@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary patency (time frame: 2 years for each patient after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03405233, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.