NCT04059536

Registry Study to Evaluate the Performance and Safety of Roxwood Medical Catheters in Arteries of Participants With a Stenotic Lesion or Chronic Total Occlusion (CTO)

Performance and Safety of the Roxwood CenterCross™ CenterCross™ Ultra, CenterCross™ Ultra LV and MultiCross™ Catheters and MicroCross™ MicroCatheter in Native Coronary and Peripheral Arteries With a Stenotic Lesion or Chronic Total Occlusion (CTO)

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this registry study is to gather real world standard of care (SOC) data on the safety and performance on the Roxwood Medical catheter devices in the treatment of stenotic lesions and CTO.

Detailed description

The Roxwood Anchoring Catheters are a group of artery catheters used in participants undergoing interventional procedures. These anchoring catheters are support catheters used in conjunction with guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and/or other interventional devices beyond stenotic lesions, including CTOs. The goal of this registry study is to collect prospective observational data on the performance of the Roxwood CenterCross™, CenterCross™ Ultra, CenterCross™ Ultra LV, MultiCross™, and MicroCross™ 14, 14ES and 18 MicroCatheter devices through 24 hours and the safety of the devices through 30 days in native coronary and peripheral arteries with a stenotic lesion or CTO. Additionally, the catheters will be evaluated for the ability to facilitate a guidewire successfully penetrating the proximal cap of the stenotic lesion or CTO and the infusion of saline and contrast agents as confirmed by angiography. Of the 100 intended participants to be treated, it is anticipated that at least 50 participants will be enrolled and treated using the Roxwood MicroCross™ 14, 14ES and/or 18 MicroCatheter and 50 participants will be enrolled and treated using the CenterCross™, CenterCross™ Ultra, CenterCross™ Ultra LV, and/or MultiCross™ devices. Adverse Events will be coded according to Medical Dictionary for Regulatory Activities (MedDRA). Data from the study will be collected via electronic data capture (EDC). Clinical data will be extracted in the desired format by the BTG Data Management from the EDC on an ongoing basis to support data review activities. An independent monitor will visit the investigational site and review the Electronic Case Report Forms (eCRFs). Data entered in the EDC will be immediately saved to a central database and changes tracked to provide an audit trail.

Conditions

• Chronic Total Occlusion
• Atherosclerosis
• Coronary Artery Disease
• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	Roxwood Anchoring Catheters	Anchoring catheters
DRUG	Acetylsalicylic Acid	Oral Tablet
DRUG	Heparin	Intravenous Injection

Timeline

• Start date: 2019-10-31
• Primary completion: 2019-12-01
• Completion: 2020-03-31
• First posted: 2019-08-16
• Last updated: 2021-07-21

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study