Restenosis Following Paclitaxel Eluting Balloon Angioplasty of Hemodialysis Access Stenosis

NCT01001676 | Completed Phase 2

• 1 other identifier: ktt1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Narrowing of the draining vein occurs in \>50% of hemodialysis fistula and left untreated will lead to loss of access. The narrowing is due to excessive growth of tissue in the vessel wall (intimal hyperplasia). The standard treatment is balloon dilatation. However, narrowing will inevitably recur in 2-3 months hence requiring further dilatation. Intimal hyperplasia also occurs in the heart and leg circulation. The drug paclitaxel has been used with great success in preventing intimal hyperplasia in these vessels following balloon dilatation. Administer locally, paclitaxel inhibits excess tissue growth in the vessel wall. The investigators believe that this drug will have similar effect in hemodialysis access.. Objective: To assess the effect of paclitaxel in hemodialysis access with narrowing. Paclitaxel is delivered by a paclitaxel-coated balloon. This balloon dilates the narrow segment and simultaneously delivers paclitaxel to the vessel wall. Methodology: Patients with narrowed hemodialysis access are dilated with the paclitaxel-coated balloon or conventional balloon in randomized manner. The patency of the two groups are evaluated and compared at 6 months follow-up. Potential benefit: Decrease number of balloon dilatations and hence hospital admissions, improve dialysis fistula function, and decrease overall economic cost.

Conditions

Renal Failure

Keywords

renal failure; Restenosis; Dialysis access; Paclitaxel; Angioplasty; Intimal hyperplasia

Outcome Measures

Primary Outcomes (1)

• Primary patency

  at 6 months

Secondary Outcomes (1)

• Transonic blood flows

  monthly for up to 6 months

Study Arms (2)

Conventional Balloon Angioplasty

ACTIVE COMPARATOR

Device: Percutaneous Transluminal Angioplasty (PTA)

Drug Eluting Balloon Angioplasty

EXPERIMENTAL

Device: Paclitaxel Eluting Balloon Angioplasty

Interventions

Percutaneous Transluminal Angioplasty (PTA) DEVICE

Angioplasty with the use of Conventional balloon

Conventional Balloon Angioplasty

Paclitaxel Eluting Balloon Angioplasty DEVICE

Angioplasty with the use of paclitaxel eluting balloon

Also known as: Passeo-18 Lux (Biotronik)

Drug Eluting Balloon Angioplasty

Eligibility Criteria

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

You may qualify if:

• Hemodialysis access located in the forearm or upper arm
• Patient with clinical or hemodynamic evidence of graft dysfunction
• Hemodialysis access is \> 3 months old

You may not qualify if:

• Intervention of the vascular access circuit within the past 30 days
• Thrombosed/clotted access
• Evidence of systemic infection or a local infection associated with the graft
• Positive pregnancy test within 7 days before enrolment
• Patient is scheduled for a kidney transplant

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Kong Teng Tan, BCh MB

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: October 27, 2009
• Study Start: February 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 17, 2014

Record last verified: 2012-01

Locations

CA (1)