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)

July 15, 2021 updated by: Boston Scientific Corporation

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)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Dignity Health d/b/a St. Joseph's Hospital & Medical Center
    • Florida
      • Gainesville, Florida, United States, 32605
        • Cardiovascular Research of North Florida LLC
    • Indiana
      • Hobart, Indiana, United States, 46342
        • St. Mary Medical Center, Inc.
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • MedStar Health Research Institute, Inc.
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Ascension St. John Hospital
      • Flint, Michigan, United States, 48501
        • McLaren Healthcare Corporation
      • Grand Blanc, Michigan, United States, 48439
        • McLaren Healthcare Corporation
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • WellSpan Health Corporation
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with chronic total occlusions or stenotic lesions will be screened. The chronic lesions must have occluded the arteries for at least 3 months or longer to be included in this study. Participants undergoing percutaneous revascularization of the native coronary or peripheral vessel where a Roxwood CenterCross™, CenterCross™ Ultra, CenterCross™ Ultra LV, MultiCross™, and MicroCross™ 14, 14ES and 18 MicroCatheter device may be utilized in an attempt at crossing a stenotic lesion or CTO. Up to 12 investigational sites in the United States will participate in this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Roxwood Anchoring Catheters
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.
Device: Roxwood Anchoring Catheters
Anchoring catheters
Other Names:
  • Roxwood CenterCross™ Catheter - 125 centimeters (cm) working length
  • CenterCross™ ULTRA Catheter - 125 cm working length
  • CenterCross™ ULTRA LV Catheter - 100 cm working length
  • MultiCross™ Catheter - 135 cm working length
  • MicroCross™ 14 Microcatheter- 135 cm working length
  • MicroCross™ 14 Microcatheter - 155 cm working length
  • MicroCross™ 14ES Extra Support Microcatheter - 135 cm working length
  • MicroCross™ 18 Microcatheter - 90 cm working length
  • MicroCross™ 18 Microcatheter - 135 cm working length
  • MicroCross™ 18 Microcatheter - 155 cm working length
Drug: Acetylsalicylic Acid
Oral Tablet
Other Names:
  • Aspirin
Drug: Heparin
Intravenous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with a Successful Index Procedure by Roxwood Medical Device(s)
Time Frame: Index Procedure (Day 0) to 24 hours Post Procedure
The number of participants who are successfully treated for an index procedure by Roxwood Medical device(s) to facilitate a guidewire successfully penetrating the proximal cap of a stenotic lesion or CTO and, the infusion of saline and contrast agents, as confirmed by angiography will be measured.
Index Procedure (Day 0) to 24 hours Post Procedure
Number of Participants Without an Index Procedure Related Safety Incident Related to the Roxwood Medical Device
Time Frame: Index Procedure (Day 0) to 24 hours Post Procedure
An index procedure safety incident related to the Roxwood Medical Device is defined as a distal embolization, major perforation or dissection in need of emergent surgical intervention as confirmed by angiography, and bleeding (change from baseline hemoglobin >3 grams/deciliter [g/dL]).
Index Procedure (Day 0) to 24 hours Post Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Without an Incidence of a Major Adverse Cardiac Events (MACE) and Urgent Target Vessel Revascularization (TVR) Related to the Roxwood Medical Device
Time Frame: Index Procedure (Day 0) up to Day 30 Post Procedure
The number of participants without an incidence of a MACE and TVR including, coronary artery bypass graft (CABG) and limb salvage related to the Roxwood Medical device will be measured.
Index Procedure (Day 0) up to Day 30 Post Procedure
Number of Participants Without Contrast Induced Renal Failure
Time Frame: Baseline up to 24 hours post procedure
Contrast induced renal failure is defined as a 25% increase in creatinine from Baseline through 24 hours post-procedure.
Baseline up to 24 hours post procedure
Time From the Roxwood Medical Device Insertion to Penetration of the Stenotic Lesion or Proximal Cap
Time Frame: Day 0
The penetration time at Day 0 will be calculated as the time from insertion of the Roxwood Medical device(s) until stenotic lesion or CTO proximal cap penetration.
Day 0
Time From the Roxwood Medical Device to Cross the True Lumen Distally
Time Frame: Day 0
The cross time at Day 0 will be calculated as the time from insertion of the Roxwood Medical device(s) until cross the true lumen distally.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

EKOS Corporation

Investigators

  • Principal Investigator: Thomas Davis, MD, Ascension St John

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 31, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

March 31, 2020

Study Registration Dates

First Submitted

August 14, 2019

First Submitted That Met QC Criteria

August 15, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTG-007927-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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