RCT of the Cutting Balloon Versus a High Pressure Balloon... | NCT00543348

Studies
RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses

NCT00543348

Sponsor

Henry Ford Health System

Status

Withdrawn

Last Update Posted

Mar 21, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Stenosis

Interventions

CUTTING BALLOON ANGIOPLASTY
Balloon angioplasty

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Mar 2008Estimated

Completion Date

Mar 2008Estimated

First Submitted Date

Oct 11, 2007

First Submission Date that Met QC Criteria

Oct 11, 2007

First Posted Date

Oct 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2022

Last Update Posted Date

Mar 21, 2022Actual

Name	Class
Boston Scientific Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	CUTTING BALLOON ANGIOPLASTY	Procedure: CUTTING BALLOON ANGIOPLASTY
2	Placebo Comparator	Balloon angioplasty with a high pressure balloon	Procedure: CUTTING BALLOON ANGIOPLASTY Procedure: Balloon angioplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CUTTING BALLOON ANGIOPLASTY	Procedure	CUTTING BALLOON	1 2

Measure	Description	Time Frame
Primary and assisted patency		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Arteriovenous prosthetic grafts

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GEORGES HADDAD, MD, FACS	Henry Ford Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henry Ford Hospital		Detroit	Michigan	48202	United States

Condition Browse Module

MeSH Terms

ID	Term
D003251	Constriction, Pathologic

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000800	Angioplasty, Balloon

Ancestor Terms

ID	Term
D017130	Angioplasty
D002404	Catheterization
D013812	Therapeutics
D057510	Endovascular Procedures

Browse Leaves

Not provided

Browse Branches

Not provided