NCT00543348

Brief Summary

The proposed study will investigate the efficacy of the peripheral cutting balloon (PBC) compared to the high pressure balloon in dilating venous stenosis in hemodialysis fistulas. 2\. SPECIFIC AIMS Study endpoints will be: Primary Endpoint 1\. Primary and assisted patency at 6 months Secondary Endpoints:

  1. 1.Procedure effectiveness/residual stenosis
  2. 2.Procedure-related complications
  3. 3.Primary patency and primary assisted patency 12 months
  4. 4.Secondary patency at 6 and 12 months
  5. 5.Number/type of secondary interventions.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

October 11, 2007

Last Update Submit

March 7, 2022

Conditions

Stenosis

Keywords

BALLOON ANGIOPLASTYAUTOGENOUS FISTULA

Outcome Measures

Primary Outcomes (1)

  • Primary and assisted patency

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

CUTTING BALLOON ANGIOPLASTY

Procedure: CUTTING BALLOON ANGIOPLASTY

2

PLACEBO COMPARATOR

Balloon angioplasty with a high pressure balloon

Procedure: CUTTING BALLOON ANGIOPLASTYProcedure: Balloon angioplasty

Interventions

CUTTING BALLOON ANGIOPLASTYPROCEDURE

CUTTING BALLOON

12
Balloon angioplastyPROCEDURE

HIGH PRESSURE BALLOON

2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dysfunctional fistulas will be recruited based on the presence of clinical and hemodialysis parameters

You may not qualify if:

  • Arteriovenous prosthetic grafts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Constriction, Pathologic

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AngioplastyCatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • GEORGES HADDAD, MD, FACS

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vascular Surgeon

Study Record Dates

First Submitted

October 11, 2007

First Posted

October 12, 2007

Study Start

September 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations

US(1)