NCT02510547

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

July 22, 2015

Last Update Submit

January 23, 2018

Conditions

ArteriosclerosisCoronary Artery DiseaseMyocardial IschemiaCoronary Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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)

  • 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)

  • +2 more secondary outcomes

Study Arms (2)

CrossBoss Catheter

ACTIVE COMPARATOR

Crossing the CTO with upfront use of the CrossBoss catheter

Procedure: CrossBoss Catheter

Antegrade Wire Escalation Strategy

ACTIVE COMPARATOR

Crossing the CTO with upfront antegrade wire escalation strategy

Procedure: Antegrade Wire Escalation Strategy

Interventions

CrossBoss CatheterPROCEDURE

Upfront use of the CrossBoss catheter for CTO lesion crossing

CrossBoss Catheter
Antegrade Wire Escalation StrategyPROCEDURE

Upfront guidewire escalation strategy for CTO lesion crossing

Antegrade Wire Escalation Strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or greater
  • Willing and able to give informed consent
  • Undergoing clinically-indicated CTO PCI with a planned antegrade crossing approach

You may not qualify if:

  • Plan for primary retrograde approach for CTO crossing
  • Ostial CTOs (within 5 mm of vessel ostium)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

United Heart and Vascular Clinic and United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Missouri Heart Center

Columbia, Missouri, 65201, United States

Location

St. Luke's Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Wellspan Heart and Vascular

York, Pennsylvania, 17403, United States

Location

North Central Heart/Avera Heart Hospital

Sioux Falls, South Dakota, 57108, United States

Location

VA North Texas Healthcare System

Dallas, Texas, 75216, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related 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.

    PMID: 23074346BACKGROUND

  • 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.

    PMID: 26028653BACKGROUND

MeSH Terms

Conditions

ArteriosclerosisCoronary Artery DiseaseMyocardial IschemiaCoronary Disease

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesHeart Diseases

Study Officials

  • Emmanouil S Brilakis, MD, PhD

    North Texas Veterans Healthcare System

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emmanouil Brilakis, MD, PhD

Study Record Dates

First Submitted

July 22, 2015

First Posted

July 29, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

US(11)