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)

Boston Scientific

Status: Withdrawn

Conditions: Coronary Artery Disease; Peripheral Artery Disease; Chronic Total Occlusion; Atherosclerosis

Treatments: Drug: Heparin; Device: Roxwood Anchoring Catheters; Drug: Acetylsalicylic Acid

Study type: Observational

Funder types: Industry

Identifiers

NCT04059536

BTG-007927-01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Roxwood CenterCross™, CenterCross™ Ultra, CenterCross™® Ultra LV, MultiCross™ and MicroCross™ 14, 14ES and 18 MicroCatheter device(s) used in first attempts at crossing the stenotic lesion or CTO
• CTO lesion >3 months
• Thrombolysis in myocardial infarction (TIMI) 0 or 1
• Coronary lesion of at least 2.5 millimeter (mm) in diameter
• Native arterial lesions only
• Peripheral lesions no minimum diameter or length
• Adult aged 25 - 80
• Participant understands and has signed the study informed consent form
• Left ventricle ejection fraction >25% (coronary enrollments only)

Exclusion criteria

• Endovascular revascularization or surgical revascularization of target lesion within <30 days of procedure

• Prior attempted CTO revascularization (during same procedure)

• Participant unable to give informed consent

• Elevated creatine kinase-muscle/brain (CK-MB) or Troponin levels at baseline

• Participant is known or suspected to be unable to tolerate the contrast agent even with pre-treatment

• CTO is located in aorto-ostial location, saphenous vein graft (SVG), or in-stent

• Appearance of a fresh thrombus or intraluminal filling defects

• Intolerance to Aspirin and/or the inability to tolerate a second antiplatelet agent (Clopidogrel, Prasugrel, Ticagrelor)

• Severe renal insufficiency with estimated glomerular filtration rate (eGFR) <30 milliliters/ minute (mL/min)/1.72 meter squared (m^2)

• Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV

• Life expectancy <6 months due to other illnesses

• Vascular graft

• Women with a positive pregnancy test

• Nitinol or nickel allergy

• Transplanted heart

• Acute or unstable medical disorder/disease that may cause a risk to participant, including:

  • Recent myocardial infarction (MI) <30 days
  • Significant anemia (for example, hemoglobin <8.0 milligram/deciliter (mg/dL)
  • Recent major cerebrovascular event (history of stroke or transient ischemic attack [TIA] within <30 days)
  • Severe uncontrolled systemic hypertension (for example, >180/100 millimeter of mercury [mmHg])
  • Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) <30 days

Trial design

0 participants in 1 patient group

Roxwood Anchoring Catheters

Description:

Participants will be treated for an index procedure using Roxwood Medical device(s) as prescribed by the Investigator SOC on Day 0. All devices will be used in accordance with the Instructions for Use (IFU). Participants are to be administered SOC acetylsalicylic acid (ASA) and/or anti-platelet medications orally per physician discretion prior to the index procedure. Administration of an intravenous injection of heparin during the index procedure will also be at the discretion of the Investigator per Institutional SOC.

Treatment:

Drug: Acetylsalicylic Acid

Device: Roxwood Anchoring Catheters

Drug: Heparin