External Ionizing Radiation to Prevent Restenosis on Haemodialysis Vascular Access

NCT00379366 | Terminated Phase 2 DMC

• 2 other identifiers: 9443-052005-011
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 5

Brief Summary

Although ionizing radiations have been proposed for the prevention of intimal hyperplasia in coronary and peripheral arteries, information is lacking on how irradiation may prevent neointimal smooth-muscle cell proliferation and restenosis on prosthetic haemodialysis vascular access. We will assess the preventive effect of one dose of radiations (14 Gy) administered transcutaneously one day after dilatation of stenosis on prosthetic haemodialysis vascular access in a randomized controlled trial with a standardized clinical and ultrasonographic one-year follow-up.

Conditions

Renal Insufficiency, Chronic; Graft Occlusion, Vascular; Thrombosis; Intimal Hyperplasia

Keywords

Randomized Controlled Trials; Renal Dialysis; Graft Occlusion, Vascular; Angioplasty; Vascular Patency; Radiation, Ionizing

Outcome Measures

Primary Outcomes (1)

• Thrombosis or stenosis > to 70% or indication of a new treatment of stenosis during the 12 month follow-up

  1, 3, 6 and 12 month after initial angioplasty

Secondary Outcomes (2)

• Stenosis (> to 70%) or thrombosis or indication of a new treatment occurring

  1, 3, 6 or 12 months after initial angioplasty

• safety

  1, 3, 6 and months after initial angioplasty

Study Arms (2)

1

ACTIVE COMPARATOR

14 Gy ionizing radiations

Device: External ionizing radiations

2

NO INTERVENTION

Interventions

External ionizing radiations DEVICE

14 Gy in one time

1

Eligibility Criteria

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

You may qualify if:

• over 18 years
• successful angioplasty (residual stenosis \< 30%) on a significant stenosis (maximal systolic speed 3 times \> from basal maximal systolic speed, stenosis \> 70% on angiography) on the venous-prosthesis anastomosis or on the venous segment 5 cm after the anastomosis of a prosthetic haemodialysis vascular access (at least 1 month old)
• social security affiliation
• signed informed consent

You may not qualify if:

• contra-indications of radiotherapy
• angioplasty with stenting

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Ministry of Health, France: collaborator

Study Sites (5)

Clinc Delay

Bayonne, 64100, France

Location

Côte Basque Hospital

Bayonne, 64109, France

Location

Clinic Saint Augustin

Bordeaux, 33000, France

Location

Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux

Bordeaux, 33076, France

Location

Clinic Francheville

Périgueux, 24000, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Graft Occlusion, Vascular; Thrombosis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jean-Philippe MAIRE, Pr

  University Hospital, Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Paul Perez, Dr

  University Hospital, Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2006
• First Posted: September 21, 2006
• Study Start: December 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

FR (5)