Trials / Withdrawn
WithdrawnNCT00543348
RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
A Randomised-Controlled Study Comparing the Peripheral Cutting BalloonTM (Boston Scientific Co.) With a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Henry Ford Health System · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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. Procedure effectiveness/residual stenosis 2. Procedure-related complications 3. Primary patency and primary assisted patency 12 months 4. Secondary patency at 6 and 12 months 5. Number/type of secondary interventions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | CUTTING BALLOON ANGIOPLASTY | CUTTING BALLOON |
| PROCEDURE | Balloon angioplasty | HIGH PRESSURE BALLOON |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2008-03-01
- Completion
- 2008-03-01
- First posted
- 2007-10-12
- Last updated
- 2022-03-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00543348. Inclusion in this directory is not an endorsement.