CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00801710|
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : December 4, 2009
This study is to determine if the BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) can facilitate safe and effective placement of a guidewire in the true lumen of coronary vessels distal to a chronic total occlusion (CTO).
The hypothesis is that the BridgePoint Medical System can do this without an increase in major complications.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Coronary Artery Chronic Total Occlusion||Device: BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||September 2009|
|Experimental: BridgePoint Medial System||
Device: BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)
Revascularization of coronary artery chronic total occlusion.
Use of the BridgePoint Medical System to cross coronary CTOs prior to definitive revascularization treatment via angioplasty and/or stent implant
- CTO Crossing Rate [ Time Frame: Peri-procedural ]
- Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days ]
- Perforation rate [ Time Frame: Peri-procedural ]
- Acute myocardial infarction (AMI) [ Time Frame: Peri-procedural ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801710
|Main Taunus Hospital|
|Bad Soden, Germany|
|CardioVascular Center Frankfurt, St. Katharinen Hospital|
|Universitäres Herz- und Gefässzentrum Hamburg|
|Principal Investigator:||Horst Sievert, MD||CardioVascular Center Frankfurt, St. Katharinen Hospital|