RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/2/2016 |
| Start Date: | September 2007 |
A Randomised-Controlled Study Comparing the Peripheral Cutting BalloonTM (Boston Scientific Co.) With a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
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.
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.
Inclusion Criteria:
- Dysfunctional fistulas will be recruited based on the presence of clinical and
hemodialysis parameters
Exclusion Criteria:
- Arteriovenous prosthetic grafts
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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