Trials / Terminated
TerminatedNCT01168024
Contrast Media Reduction and Removal in Patients With Chronic Kidney Disease (CKD) (PRESERV)
PRESERV (Prospective Randomized Evaluation to Study the Effects of Reduced Contrast Media on the Vitality of the Kidney) Pivotal Trial
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Osprey Medical, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical trial is to demonstrate the efficacy and safety of the Osprey Medical CINCOR™ Contrast Removal System.
Detailed description
The CINCOR™ Catheter System to retrieve contrast media from the coronary sinus following injection during percutaneous coronary interventions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CINCOR™ System and contrast conservation unit (CCS-1) | Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media |
| OTHER | Standard of Care plus peri-procedural hydration | The control group will receive a peri and post-procedural hydration rate. |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2013-10-01
- Completion
- 2013-11-01
- First posted
- 2010-07-22
- Last updated
- 2016-12-12
- Results posted
- 2016-12-12
Locations
21 sites across 2 countries: United States, Germany
Source: ClinicalTrials.gov record NCT01168024. Inclusion in this directory is not an endorsement.