Clinical trial NCT02510547: Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial
Official title: Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
Collaborators: name: Henry Ford Hospital
name: Massachusetts General Hospital
name: North Central Heart-Avera Sacred Heart Hospital
name: Saint Lukes Hospital Mid America Heart Institute
name: Missouri Heart Center
name: University of Washington
name: Deborah Heart and Lung Center
name: Minneapolis Heart Institute
name: Wellspan Heart and Vascular
name: United Heart and Vascular Clinic and United Hospital
First posted: 2015-07-29
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: Until Hospital Discharge (usually 1 day after procedure)
Secondary outcomes:
measure: Procedure time to Cross the CTO
timeFrame: Until end of procedure (usually 2-3 hours after procedure starts)
measure: Technical and procedural success
timeFrame: Until end of procedure (usually 2-3 hours after procedure starts)
measure: Total procedure time
timeFrame: Until end of procedure (usually 2-3 hours after procedure starts)
measure: Fluoroscopy time to cross CTO and total fluoroscopy time
timeFrame: Until end of procedure (usually 2-3 hours after procedure starts)
measure: Total air kerma radiation exposure
timeFrame: Until end of procedure (usually 2-3 hours after procedure starts)
measure: Total contrast volume
timeFrame: Until end of procedure (usually 2-3 hours after procedure starts)
measure: Number of wires, microcatheters balloons and stents used.
timeFrame: Until end of procedure (usually 2-3 hours after procedure starts)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Saint Paul
country: United States
facility: United Heart and Vascular Clinic and United Hospital
state: Minnesota
city: Columbia
country: United States
facility: Missouri Heart Center
state: Missouri
city: Kansas City
country: United States
facility: St. Luke's Mid America Heart Institute
state: Missouri
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: York
country: United States
facility: Wellspan Heart and Vascular
state: Pennsylvania
city: Sioux Falls
country: United States
facility: North Central Heart/Avera Heart Hospital
state: South Dakota
city: Dallas
country: United States
facility: VA North Texas Healthcare System
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: North Texas Veterans Healthcare System
name: Emmanouil S Brilakis, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.