Arteriosclerosis, Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
Conditions
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.
Interventions
PROCEDURECrossBoss Catheter
Upfront use of the CrossBoss catheter for CTO lesion crossing
PROCEDUREAntegrade Wire Escalation Strategy
Upfront guidewire escalation strategy for CTO lesion crossing
Sponsors
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
North Texas Veterans Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| Procedure time to Cross the CTO | 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) | — |
| Total air kerma radiation exposure | Until end of procedure (usually 2-3 hours after procedure starts) | — |
Countries
United States
Outcome results
None listed