Arteriovenous Fistula Complications and FailureNCT01669850
Clipped Versus Handsewn Arteriovenous Fistula Anastomosis
A study testing Clipped anastomosis and Handsewn anastomosis in people with Arteriovenous Fistula Complications and Failure, run by Gundersen Lutheran Medical Foundation at 1 site in United States.
Trial summary
The purpose of this study is to determine whether handsewn anastomosis versus clipped technique is associated with more complications, fistula failures, surgical cost and surgical time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula Complications and Failure
- What is being tested?
- Clipped anastomosis and Handsewn anastomosis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Need for AVF creation for vascular access for planned hemodialysis (within 1 year).
- The planned AVF site must be naïve of prior AVF creations.
- Vein mapping studies completed
- 2.5 - 3mm minimum vein diameter on mapping
Who cannot join
- Less than 18 years of age.
- Inability to provide consent.
- Previous failed AVFs in both arms.
- Contraindications to AVF creation:
- ipsilateral proximal venous and arterial occlusion or stenosis
- systemic or local infection
- too ill to operate
- Anticipated inability to keep 30-day postoperative follow-up appointment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gundersen Lutheran Health System
La Crosse, Wisconsin, 54601
About this study
Official title: The Safety and Effectiveness of Clipped Technique vs. Hand-Sewn Technique for Anastomosis in Arteriovenous Fistulas
The purpose of this study is to determine whether handsewn anastomosis versus clipped technique is associated with more complications, fistula failures, surgical cost and surgical time.
Read the detailed description
End stage renal disease requiring hemodialysis has become more prevalent in recent years. Achieving vascular access is an important step in receiving hemodialysis. Recent national goals have established that approximately 65% of all dialysis access points should be arteriovenous fistulas due to higher patency rates and decreased rates of further surgeries. Multiple studies have been done to assess optimal suture technique for arteriovenous anastomoses. The use of clips versus a handsewn technique has been evaluated in retrospective studies with some reports indicating a higher primary patency rate with a clip technique. Further study is needed to definitively determine the technique that results in the highest patency rates and lowest rate of re-operation. The purpose of this study is to determine whether hand-sewn anastomosis versus a clipped technique is associated with more complications, failures, surgical cost and surgical time by randomizing patients to either a clipped anastomosis group or a handsewn anastomosis group.
- Being tested
- Clipped anastomosis, Handsewn anastomosis
- Keywords
- Chronic kidney disease, Arteriovenous fistula, Surgical anastomosis, Complications, Patency, Dialysis access
- Medical subject headings
- Renal Insufficiency, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clipped anastomosisDevice
Also called Anastoclip (Le Maitre)
The vascular clip devise will be used to complete the anastomosis during fistula creation.
Handsewn anastomosisProcedure or surgery
a handsewn anastomosis technique will be used during fistula creation.
| Study group | Role | What they receive |
|---|---|---|
| Clipped anastomosis | Experimental | A vascular clip device will be used to create the anastomosis during arteriovenous fistula creation. Receives: Device: Clipped anastomosis |
| Handsewn anastomosis | Active comparator | A handsewn technique will be used to create the anastomosis in arteriovenous fistula creation. Receives: Procedure: Handsewn anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency rates
Patency will be assessed and the fistula considered patent if it has been accessed for dialysis at least once, or based on clinical assessment with palpable thrill if dialysis access has not been attempted.
Measured: 2 years postoperative
Secondary outcomes (1)
Surgical complications
Complications will be monitored intraoperatively, and postoperatively. These include any re-interventions, and wound complications, infection, hematoma, thrombosis , steal syndrome, distal ischemia.
Measured: 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: minimal accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous Fistula Complications and FailureStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gundersen Lutheran Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Gundersen Lutheran Health System
- Responsible party
- Principal investigator, Kara Kallies, Gundersen Lutheran Medical Foundation
- Investigators
- Clark A Davis, MD, Principal investigator, Gundersen Lutheran Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669850
- Sponsor's protocol ID
- 2-12-07-002
- Status last verified
- Sep 2015
- First submitted
- 16 Aug 2012
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Baguneid MS, Goldner S, Fulford PE, Hamilton G, Walker MG, Seifalian AM. A comparison of para-anastomotic compliance profiles after vascular anastomosis: nonpenetrating clips versus standard sutures. J Vasc Surg. 2001 Apr;33(4):812-20. doi: 10.1067/mva.2001.112806.
PubMed 11296337Lin PH, Bush RL, Nelson JC, Lam R, Paladugu R, Chen C, Quinn G, Lumsden AB. A prospective evaluation of interrupted nitinol surgical clips in arteriovenous fistula for hemodialysis. Am J Surg. 2003 Dec;186(6):625-30. doi: 10.1016/j.amjsurg.2003.08.007.
PubMed 14672769Varcoe RL, Teo AB, Pelletier MH, Yu Y, Yang JL, Crowe PJ, Walsh WR. An arteriovenous fistula model of intimal hyperplasia for evaluation of a nitinol U-Clip anastomosis. Eur J Vasc Endovasc Surg. 2012 Feb;43(2):224-31. doi: 10.1016/j.ejvs.2011.11.002. Epub 2011 Nov 21.
PubMed 22104322Shenoy S, Miller A, Petersen F, Kirsch WM, Konkin T, Kim P, Dickson C, Schild AF, Stewart L, Reyes M, Anton L, Woodward RS. A multicenter study of permanent hemodialysis access patency: beneficial effect of clipped vascular anastomotic technique. J Vasc Surg. 2003 Aug;38(2):229-35. doi: 10.1016/s0741-5214(03)00412-9.
PubMed 12891102Shenoy S, Woodward RS. Economic impact of the beneficial effect of changing vascular anastomotic technique in hemodialysis access. Vasc Endovascular Surg. 2005 Sep-Oct;39(5):437-43. doi: 10.1177/153857440503900509.
PubMed 16193217
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of Clipped Technique vs. Hand-Sewn Technique for Anastomosis in Arteriovenous Fistulas
- ClinicalTrials.gov ID
- NCT01669850
- Acronym / sponsor ID
- 2-12-07-002
- Keywords
- Chronic kidney disease, Arteriovenous fistula, Surgical anastomosis, Complications, Patency, Dialysis access
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: minimal accrual
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Gundersen Lutheran Medical FoundationUniversity, hospital or other
- Collaborators
- Gundersen Lutheran Health System
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Aug 2012 (estimated)
- 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.
The purpose of this study is to determine whether handsewn anastomosis versus clipped technique is associated with more complications, fistula failures, surgical cost and surgical time.
Detailed description
End stage renal disease requiring hemodialysis has become more prevalent in recent years. Achieving vascular access is an important step in receiving hemodialysis. Recent national goals have established that approximately 65% of all dialysis access points should be arteriovenous fistulas due to higher patency rates and decreased rates of further surgeries. Multiple studies have been done to assess optimal suture technique for arteriovenous anastomoses. The use of clips versus a handsewn technique has been evaluated in retrospective studies with some reports indicating a higher primary patency rate with a clip technique. Further study is needed to definitively determine the technique that results in the highest patency rates and lowest rate of re-operation. The purpose of this study is to determine whether hand-sewn anastomosis versus a clipped technique is associated with more complications, failures, surgical cost and surgical time by randomizing patients to either a clipped anastomosis group or a handsewn anastomosis group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clipped anastomosis | Experimental | Device: Clipped anastomosisA vascular clip device will be used to create the anastomosis during arteriovenous fistula creation. |
| Handsewn anastomosis | Active comparator | Procedure: Handsewn anastomosisA handsewn technique will be used to create the anastomosis in arteriovenous fistula creation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older.
- Need for AVF creation for vascular access for planned hemodialysis (within 1 year).
- The planned AVF site must be naïve of prior AVF creations.
- Vein mapping studies completed
- 2.5 - 3mm minimum vein diameter on mapping
Key exclusion criteria (8 listed)
- Less than 18 years of age.
- Inability to provide consent.
- Previous failed AVFs in both arms.
- Contraindications to AVF creation:
- Anticipated inability to keep 30-day postoperative follow-up appointment.
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 |
|---|---|---|
| Clipped anastomosisAlso: Anastoclip (Le Maitre)The vascular clip devise will be used to complete the anastomosis during fistula creation. | Device | Clipped anastomosis |
| Handsewn anastomosisa handsewn anastomosis technique will be used during fistula creation. | Procedure or surgery | Handsewn anastomosis |
Primary outcome
Patency rates
Time frame: 2 years postoperative
Patency will be assessed and the fistula considered patent if it has been accessed for dialysis at least once, or based on clinical assessment with palpable thrill if dialysis access has not been attempted.
1 secondary outcome
Surgical complications
Time frame: 2 years postoperative
Results and safety
The study was stopped early (reason given: minimal accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Background: PubMed 11296337Baguneid MS, Goldner S, Fulford PE, Hamilton G, Walker MG, Seifalian AM. A comparison of para-anastomotic compliance profiles after vascular anastomosis: nonpenetrating clips versus standard sutures. J Vasc Surg. 2001 Apr;33(4):812-20. doi: 10.1067/mva.2001.112806.
- Background: PubMed 14672769Lin PH, Bush RL, Nelson JC, Lam R, Paladugu R, Chen C, Quinn G, Lumsden AB. A prospective evaluation of interrupted nitinol surgical clips in arteriovenous fistula for hemodialysis. Am J Surg. 2003 Dec;186(6):625-30. doi: 10.1016/j.amjsurg.2003.08.007.
- Background: PubMed 22104322Varcoe RL, Teo AB, Pelletier MH, Yu Y, Yang JL, Crowe PJ, Walsh WR. An arteriovenous fistula model of intimal hyperplasia for evaluation of a nitinol U-Clip anastomosis. Eur J Vasc Endovasc Surg. 2012 Feb;43(2):224-31. doi: 10.1016/j.ejvs.2011.11.002. Epub 2011 Nov 21.
- Background: PubMed 12891102Shenoy S, Miller A, Petersen F, Kirsch WM, Konkin T, Kim P, Dickson C, Schild AF, Stewart L, Reyes M, Anton L, Woodward RS. A multicenter study of permanent hemodialysis access patency: beneficial effect of clipped vascular anastomotic technique. J Vasc Surg. 2003 Aug;38(2):229-35. doi: 10.1016/s0741-5214(03)00412-9.
- Background: PubMed 16193217Shenoy S, Woodward RS. Economic impact of the beneficial effect of changing vascular anastomotic technique in hemodialysis access. Vasc Endovascular Surg. 2005 Sep-Oct;39(5):437-43. doi: 10.1177/153857440503900509.
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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.
Clark A Davis, MD principal investigator
Gundersen Lutheran Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clipped anastomosis and Handsewn anastomosis in people with Arteriovenous Fistula Complications and Failure, run by Gundersen Lutheran Medical Foundation at 1 site in United States.
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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 7 Sep 2015. 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 United States. 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?
The study was stopped early (reason given: minimal accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency rates (time frame: 2 years postoperative). 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 NCT01669850, which also lists 5 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 7 Sep 2015.