Coronary Artery Disease Clinical Trial
Official title:
Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial
Verified date | January 2018 |
Source | North Texas Veterans Healthcare System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 246 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Deborah Heart and Lung Center | Browns Mills | New Jersey |
United States | Missouri Heart Center | Columbia | Missouri |
United States | VA North Texas Healthcare System | Dallas | Texas |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | St. Luke's Mid America Heart Institute | Kansas City | Missouri |
United States | Minneapolis Heart Institute | Minneapolis | Minnesota |
United States | United Heart and Vascular Clinic and United Hospital | Saint Paul | Minnesota |
United States | University of Washington Medical Center | Seattle | Washington |
United States | North Central Heart/Avera Heart Hospital | Sioux Falls | South Dakota |
United States | Wellspan Heart and Vascular | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
North Texas Veterans Healthcare System | Deborah Heart and Lung Center, Henry Ford Hospital, Massachusetts General Hospital, Minneapolis Heart Institute, Missouri Heart Center, North Central Heart-Avera Sacred Heart Hospital, Saint Lukes Hospital Mid America Heart Institute, United Heart and Vascular Clinic and United Hospital, University of Washington, Wellspan Heart and Vascular |
United States,
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. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major Adverse Cardiovascular Events | Incidence of procedural major adverse cardiovascular events (MACE, composite death, emergent coronary artery bypass graft surgery, tamponade requiring pericardiocentesis, and stroke) | Until Hospital Discharge (usually 1 day after procedure) | |
Secondary | Procedure time to Cross the CTO | Until end of procedure (usually 2-3 hours after procedure starts) | ||
Secondary | Technical and procedural success | Until end of procedure (usually 2-3 hours after procedure starts) | ||
Secondary | Total procedure time | Interval between administration of local anesthesia for obtaining vascular access and removal of the last catheter) | Until end of procedure (usually 2-3 hours after procedure starts) | |
Secondary | Fluoroscopy time to cross CTO and total fluoroscopy time | Until end of procedure (usually 2-3 hours after procedure starts) | ||
Secondary | Total air kerma radiation exposure | Until end of procedure (usually 2-3 hours after procedure starts) | ||
Secondary | Total contrast volume | Until end of procedure (usually 2-3 hours after procedure starts) | ||
Secondary | Number of wires, microcatheters balloons and stents used. | Until end of procedure (usually 2-3 hours after procedure starts) |
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