Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial
Study Details
Study Description
Brief Summary
CrossBoss First is a single-blind randomized controlled trial that will randomize 246 patients undergoing clinically-indicated Chronic Total Occlusion Percutaneous Coronary Intervention, to upfront use of the CrossBoss catheter vs. antegrade guidewire escalation strategy The "CrossBoss First" study has two primary objectives. The primary efficacy objective is to compare the procedure time required to cross the CTO or abort the procedure with a CrossBoss first vs. antegrade wire escalation strategy. The investigators hypothesize that upfront use of the CrossBoss catheter will be associated with shorter procedure time required for CTO crossing compared with an antegrade wire escalation strategy.
The primary safety objective is to compare the frequency of procedural major adverse cardiovascular events (MACE) with upfront use of CrossBoss vs. a guidewire escalation strategy. The investigators hypothesize that upfront use of the CrossBoss catheter will be associated with similar incidence of MACE compared with an antegrade wire escalation strategy.
The secondary endpoints are: (1) technical and procedural success4-6; (2) total procedure time (defined as the interval between administration of local anesthesia for obtaining vascular access and removal of the last catheter); (3) fluoroscopy time to cross the CTO and total fluoroscopy time; (4) total air kerma radiation exposure; (5) total contrast volume; and (6) number of wires, microcatheters, balloons, and stents used.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: CrossBoss Catheter Crossing the CTO with upfront use of the CrossBoss catheter |
Procedure: CrossBoss Catheter
Upfront use of the CrossBoss catheter for CTO lesion crossing
|
| Active Comparator: Antegrade Wire Escalation Strategy Crossing the CTO with upfront antegrade wire escalation strategy |
Procedure: Antegrade Wire Escalation Strategy
Upfront guidewire escalation strategy for CTO lesion crossing
|
Outcome Measures
Primary Outcome Measures
- Major Adverse Cardiovascular Events [Until Hospital Discharge (usually 1 day after procedure)]
Incidence of procedural major adverse cardiovascular events (MACE, composite death, emergent coronary artery bypass graft surgery, tamponade requiring pericardiocentesis, and stroke)
Secondary Outcome Measures
- Procedure time to Cross the CTO [Until end of procedure (usually 2-3 hours after procedure starts)]
- Technical and procedural success [Until end of procedure (usually 2-3 hours after procedure starts)]
- Total procedure time [Until end of procedure (usually 2-3 hours after procedure starts)]
Interval between administration of local anesthesia for obtaining vascular access and removal of the last catheter)
- Fluoroscopy time to cross CTO and total fluoroscopy time [Until end of procedure (usually 2-3 hours after procedure starts)]
- Total air kerma radiation exposure [Until end of procedure (usually 2-3 hours after procedure starts)]
- Total contrast volume [Until end of procedure (usually 2-3 hours after procedure starts)]
- Number of wires, microcatheters balloons and stents used. [Until end of procedure (usually 2-3 hours after procedure starts)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 years or greater
-
Willing and able to give informed consent
-
Undergoing clinically-indicated CTO PCI with a planned antegrade crossing approach
Exclusion Criteria:
-
Plan for primary retrograde approach for CTO crossing
-
Ostial CTOs (within 5 mm of vessel ostium)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 2 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 3 | Minneapolis Heart Institute | Minneapolis | Minnesota | United States | 55407 |
| 4 | United Heart and Vascular Clinic and United Hospital | Saint Paul | Minnesota | United States | 55102 |
| 5 | Missouri Heart Center | Columbia | Missouri | United States | 65201 |
| 6 | St. Luke's Mid America Heart Institute | Kansas City | Missouri | United States | 64111 |
| 7 | Deborah Heart and Lung Center | Browns Mills | New Jersey | United States | 08015 |
| 8 | Wellspan Heart and Vascular | York | Pennsylvania | United States | 17403 |
| 9 | North Central Heart/Avera Heart Hospital | Sioux Falls | South Dakota | United States | 57108 |
| 10 | VA North Texas Healthcare System | Dallas | Texas | United States | 75216 |
| 11 | University of Washington Medical Center | Seattle | Washington | United States | 98195 |
Sponsors and Collaborators
- North Texas Veterans Healthcare System
- Henry Ford Hospital
- Massachusetts General Hospital
- North Central Heart-Avera Sacred Heart Hospital
- Saint Lukes Hospital Mid America Heart Institute
- Missouri Heart Center
- University of Washington
- Deborah Heart and Lung Center
- Minneapolis Heart Institute
- Wellspan Heart and Vascular
- United Heart and Vascular Clinic and United Hospital
Investigators
- Study Chair: Emmanouil S Brilakis, MD, PhD, North Texas Veterans Healthcare System
Study Documents (Full-Text)
None provided.More Information
Publications
- Michael TT, Papayannis AC, Banerjee S, Brilakis ES. Subintimal dissection/reentry strategies in coronary chronic total occlusion interventions. Circ Cardiovasc Interv. 2012 Oct;5(5):729-38. doi: 10.1161/CIRCINTERVENTIONS.112.969808. Review.
- Wosik J, Shorrock D, Christopoulos G, Kotsia A, Rangan BV, Roesle M, Maragkoydakis S, Abdullah SM, Banerjee S, Brilakis ES. Systematic Review of the BridgePoint System for Crossing Coronary and Peripheral Chronic Total Occlusions. J Invasive Cardiol. 2015 Jun;27(6):269-76. Review.
- 15-010