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| autoid | 17 |
| crg_id | CRG080500007 |
| titleoftrial | Endovascular versus surgical pre-emptive repair of forearm arterio-venous fistula juxta-anastomotic stenosis: a prospective controlled concurrent trial |
| acronymnoftrial | PTA vs Surgery in pre-emptive repair of stenosed AVFs |
| website | http:// |
| identificationno | |
| leadprefix | Dr |
| leadsurname | Tessitore |
| leadgivennames | Nicola |
| leadposition | Chief - Hemodialysis Unit Ospedale Policlinico |
| leaddepartment | Division of Nephrology |
| leadorganisation | Azienda Ospedaliera di Verona |
| leadaddress | Piazzale LA Scuro 10 - 37134 Verona, Italy |
| leademail | nicola.tessitore@azosp.vr.it |
| leadphone | +39 045 8074652 |
| leadfax | +39 045 8074687 |
| leadsuffix | |
| contactprefix | Dr |
| contactsurname | |
| contactgivennames | |
| contactposition | |
| contactdepartment | |
| contactorganisation | |
| contactaddress | |
| contactemail | |
| contactphone | |
| contactfax | |
| funding | |
| otherfunding | no funding |
| fundingnameofsponsors | |
| ethicsapproval | no |
| studytype | nonrandomised |
| studytype_other | prospective controlled concurrent |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | 01/1999 |
| actualstart | 01/1999 |
| proposedcompletiondate | 01/2004 |
| actualcompletiondate | 11/2004 |
| multi_center_study | no |
| numberofcentres | |
| multi_national_study | no |
| countrycentres | Italy |
| researchquestion | Both surgery and angioplasty (PTA) are used in the pre-emptive repair of perianastomotic stenosis in forearm arterio-venous fistulae (AVFs).Surgery is considered the preferred treatment (Bakran et al:Vascular Access Society Guidelines.Pabst Science Pub.,2003), because it is minimally invasive and primary patency rates in surgical series are higher than after dilatation.No prospective comparative trials betwwen the two procedures have been reported todate. We performed a retrospective analysis of prospectively collected concurrent data to compare cot-effectiveness of surgery and PTA in the pre-emptive treatment of perianastomotic stenoses in forearm AVFs. |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | completed |
| healthcarecondition | Chronic hemodialysis, arteriovenous fistula, repair of stenosis |
| intervention1 | Pre-emptive surgical revision of stenosis.Since guidelines consider surgery the treatment of choice, the surgical group was considered the Control arm of the study. |
| intervention2 | Pre-emptive angioplasty |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | |
| age | 25 - 85 |
| totalrecruitment | |
| inclusion | Hemodialysis patients with functioning(able to provide adequate dialysis), mature, forearm AVFs with angiographically-proven significant (> 50 %)juxta-anastomotic venous (first 5 cm of the draining vein) stenosis |
| exclusion | Hemodialysis patients with prostethic grafts or upper-arm or elbow AVFs or forearm non-stenotic AVFs or malfunctioning AVFs |
| primaryoutcomes | 1)Restenosis interval, equivalent to post-intervention primary patency and defined as the interval between the surgical or endovascular procedure to restenosis or access thrombosis. Restenosis was angiographically-proven and it was identified by surveillance based on quarterly access blood flow (Qa) measurement. 2)Intervention procedure failure, equivalent to post-intervention assisted primary patency and defined as the interval between the surgical or endovascular procedure and re-intervention by another procedure or access thrombosi or access abandonment. |
| secondaryoutcomes | To compare direct access-care related costs of the two procedures, including all expenses for correcting stenosis and for treat procedure failure. |
| reference | Tessitore N, Lipari G et al. A prospective controlled trial on surgical vs endovascular treatment of stenosis in foreman arteriovenous fistulae (AVF)[abstract no: SU-FC082]. Journal of the American Society of Nephrology 2004; 15 Oct Abstracts: 61A [Free Communication. ASN Renal Week, St Louis,MO, October 27-November 1, 2004] |