Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510547
• Other study ID #: 15-010
• Status: Completed
• Phase: Phase 4
• First received: July 22, 2015
• Last updated: January 23, 2018
• Start date: September 2015
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischemia

Intervention

Procedure:
• CrossBoss Catheter
Upfront use of the CrossBoss catheter for CTO lesion crossing
• Antegrade Wire Escalation Strategy
Upfront guidewire escalation strategy for CTO lesion crossing

Locations

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

Sponsors (11)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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)