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NCT02510547 · ClinicalTrials.gov registry record · Phase 4
Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial
A Phase 4 study, sponsored by North Texas Veterans Healthcare System.
- Completed
- Registry status
- Phase 4
- Development phase
- 246
- Enrollment target
NCT02510547 is a Phase 4 study that has completed, run by North Texas Veterans Healthcare System. The registered enrollment target is 246 participants.
The verdict
NCT02510547, a Phase 4 study, has completed, sponsored by North Texas Veterans Healthcare System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 246 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE CrossBoss Catheter
- PROCEDURE Antegrade Wire Escalation Strategy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2015-09 |
| Est. Completion | 2017-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02510547
The ClinicalTrials.gov registry entry for NCT02510547 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is North Texas Veterans Healthcare System, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CrossBoss Catheter is the first listed.
NCT02510547 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02510547 about?
NCT02510547 is a clinical study titled "Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial". 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 ...
What is the current status of trial NCT02510547?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 246 participants. The study started on 2015-09. Estimated completion is 2017-08.
What interventions are being tested in trial NCT02510547?
The interventions under investigation include: CrossBoss Catheter (PROCEDURE), Antegrade Wire Escalation Strategy (PROCEDURE).
Who is sponsoring clinical trial NCT02510547?
This trial is sponsored by North Texas Veterans Healthcare System, which has 23 total clinical trials registered on ClinicalTrials.gov.
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