Clinical trial 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)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Total Occlusion
Atherosclerosis
Coronary Artery Disease
Peripheral Artery Disease
Keywords: Stenotic Lesions
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: EKOS Corporation
First posted: 2019-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with a Successful Index Procedure by Roxwood Medical Device(s)
timeFrame: Index Procedure (Day 0) to 24 hours Post Procedure
measure: Number of Participants Without an Index Procedure Related Safety Incident Related to the Roxwood Medical Device
timeFrame: Index Procedure (Day 0) to 24 hours Post Procedure
Secondary outcomes:
measure: 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
timeFrame: Index Procedure (Day 0) up to Day 30 Post Procedure
measure: Number of Participants Without Contrast Induced Renal Failure
timeFrame: Baseline up to 24 hours post procedure
measure: Time From the Roxwood Medical Device Insertion to Penetration of the Stenotic Lesion or Proximal Cap
timeFrame: Day 0
measure: Time From the Roxwood Medical Device to Cross the True Lumen Distally
timeFrame: Day 0
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dignity Health d/b/a St. Joseph's Hospital & Medical Center
state: Arizona
city: Gainesville
country: United States
facility: Cardiovascular Research of North Florida LLC
state: Florida
city: Hobart
country: United States
facility: St. Mary Medical Center, Inc.
state: Indiana
city: Hyattsville
country: United States
facility: MedStar Health Research Institute, Inc.
state: Maryland
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Flint
country: United States
facility: McLaren Healthcare Corporation
state: Michigan
city: Grand Blanc
country: United States
facility: McLaren Healthcare Corporation
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: New York
country: United States
facility: Columbia University
state: New York
city: York
country: United States
facility: WellSpan Health Corporation
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Ascension St John
name: Thomas Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: