ArteriosclerosisPhase 4NCT02510547
Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial
A Phase 4 study testing CrossBoss Catheter and Antegrade Wire Escalation Strategy in people with Arteriosclerosis and Coronary Artery Disease, run by North Texas Veterans Healthcare System at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriosclerosis, Coronary Artery Disease, Myocardial Ischemia
- What is being tested?
- CrossBoss Catheter and Antegrade Wire Escalation Strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 11 sitesUnited States
- Study dates
- Sep 2015to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or greater
- Willing and able to give informed consent
- Undergoing clinically-indicated CTO PCI with a planned antegrade crossing approach
Who cannot join
- Plan for primary retrograde approach for CTO crossing
- Ostial CTOs (within 5 mm of vessel ostium)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Missouri Heart Center
Columbia, Missouri, 65201
VA North Texas Healthcare System
Dallas, Texas, 75216
Henry Ford Hospital
Detroit, Michigan, 48202
St. Luke's Mid America Heart Institute
Kansas City, Missouri, 64111
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
United Heart and Vascular Clinic and United Hospital
Saint Paul, Minnesota, 55102
University of Washington Medical Center
Seattle, Washington, 98195
North Central Heart/Avera Heart Hospital
Sioux Falls, South Dakota, 57108
Wellspan Heart and Vascular
York, Pennsylvania, 17403
About this study
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.
- Being tested
- CrossBoss Catheter, Antegrade Wire Escalation Strategy
- Medical subject headings
- Arteriosclerosis, Coronary Artery Disease, Myocardial Ischemia, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrossBoss CatheterProcedure or surgery
Upfront use of the CrossBoss catheter for CTO lesion crossing
Antegrade Wire Escalation StrategyProcedure or surgery
Upfront guidewire escalation strategy for CTO lesion crossing
| Study group | Role | What they receive |
|---|---|---|
| CrossBoss Catheter | Active comparator | Crossing the CTO with upfront use of the CrossBoss catheter Receives: Procedure: CrossBoss Catheter |
| Antegrade Wire Escalation Strategy | Active comparator | Crossing the CTO with upfront antegrade wire escalation strategy Receives: Procedure: Antegrade Wire Escalation Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Until Hospital Discharge (usually 1 day after procedure)
Secondary outcomes (7)
Procedure time to Cross the CTO
Measured: Until end of procedure (usually 2-3 hours after procedure starts)
Technical and procedural success
Measured: Until end of procedure (usually 2-3 hours after procedure starts)
Total procedure time
Interval between administration of local anesthesia for obtaining vascular access and removal of the last catheter)
Measured: Until end of procedure (usually 2-3 hours after procedure starts)
Fluoroscopy time to cross CTO and total fluoroscopy time
Measured: Until end of procedure (usually 2-3 hours after procedure starts)
Total air kerma radiation exposure
Measured: Until end of procedure (usually 2-3 hours after procedure starts)
Total contrast volume
Measured: Until end of procedure (usually 2-3 hours after procedure starts)
Number of wires, microcatheters balloons and stents used.
Measured: Until end of procedure (usually 2-3 hours after procedure starts)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ArteriosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- 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
- Responsible party
- Principal investigator, Emmanouil Brilakis, North Texas Veterans Healthcare System
- Investigators
- Emmanouil S Brilakis, MD, PhD, Study chair, North Texas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510547
- Sponsor's protocol ID
- 15-010
- Status last verified
- Jan 2018
- First submitted
- 22 Jul 2015
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23074346Wosik 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.
PubMed 26028653
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial
- ClinicalTrials.gov ID
- NCT02510547
- Acronym / sponsor ID
- 15-010
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Collaborators
- 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
- Study start
- Sep 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CrossBoss Catheter | Active comparator | Procedure: CrossBoss CatheterCrossing the CTO with upfront use of the CrossBoss catheter |
| Antegrade Wire Escalation Strategy | Active comparator | Procedure: Antegrade Wire Escalation StrategyCrossing the CTO with upfront antegrade wire escalation strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or greater
- Willing and able to give informed consent
- Undergoing clinically-indicated CTO PCI with a planned antegrade crossing approach
Key exclusion criteria (2 listed)
- Plan for primary retrograde approach for CTO crossing
- Ostial CTOs (within 5 mm of vessel ostium)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrossBoss CatheterUpfront use of the CrossBoss catheter for CTO lesion crossing | Procedure or surgery | CrossBoss Catheter |
| Antegrade Wire Escalation StrategyUpfront guidewire escalation strategy for CTO lesion crossing | Procedure or surgery | Antegrade Wire Escalation Strategy |
Primary outcome
Major Adverse Cardiovascular Events
Time frame: 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)
7 secondary outcomes
Procedure time to Cross the CTO
Time frame: Until end of procedure (usually 2-3 hours after procedure starts)
Technical and procedural success
Time frame: Until end of procedure (usually 2-3 hours after procedure starts)
Total procedure time
Time frame: Until end of procedure (usually 2-3 hours after procedure starts)
Fluoroscopy time to cross CTO and total fluoroscopy time
Time frame: Until end of procedure (usually 2-3 hours after procedure starts)
Total air kerma radiation exposure
Time frame: Until end of procedure (usually 2-3 hours after procedure starts)
Total contrast volume
Time frame: Until end of procedure (usually 2-3 hours after procedure starts)
Number of wires, microcatheters balloons and stents used.
Time frame: Until end of procedure (usually 2-3 hours after procedure starts)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Background: PubMed 23074346Michael 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.
- Background: PubMed 26028653Wosik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanouil S Brilakis, MD, PhD study chair
North Texas Veterans Healthcare System
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CrossBoss Catheter and Antegrade Wire Escalation Strategy in people with Arteriosclerosis and Coronary Artery Disease, run by North Texas Veterans Healthcare System at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: Until Hospital Discharge (usually 1 day after procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02510547, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.