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)

NCT04059536 | Withdrawn DMC FDA Device

• 1 other identifier: BTG-007927-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 11

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.

Conditions

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

Keywords

Stenotic Lesions

Outcome Measures

Primary Outcomes (2)

• Number of Participants with a Successful Index Procedure by Roxwood Medical Device(s)

  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

  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 Outcomes (4)

• 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

  Index Procedure (Day 0) up to Day 30 Post Procedure

• Number of Participants Without Contrast Induced Renal Failure

  Baseline up to 24 hours post procedure

• Time From the Roxwood Medical Device Insertion to Penetration of the Stenotic Lesion or Proximal Cap

  Day 0

• Time From the Roxwood Medical Device to Cross the True Lumen Distally

  Day 0

Study Arms (1)

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; Drug: Acetylsalicylic Acid; Drug: Heparin

Interventions

Roxwood Anchoring Catheters DEVICE

Anchoring catheters

Also known as: 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

Roxwood Anchoring Catheters

Acetylsalicylic Acid DRUG

Oral Tablet

Also known as: Aspirin

Roxwood Anchoring Catheters

Heparin DRUG

Intravenous Injection

Roxwood Anchoring Catheters

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• EKOS Corporation: collaborator

Study Sites (11)

Dignity Health d/b/a St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

Cardiovascular Research of North Florida LLC

Gainesville, Florida, 32605, United States

Location

St. Mary Medical Center, Inc.

Hobart, Indiana, 46342, United States

Location

MedStar Health Research Institute, Inc.

Hyattsville, Maryland, 20782, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

McLaren Healthcare Corporation

Flint, Michigan, 48501, United States

Location

McLaren Healthcare Corporation

Grand Blanc, Michigan, 48439, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Columbia University

New York, New York, 10032, United States

Location

WellSpan Health Corporation

York, Pennsylvania, 17403, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease; Peripheral Arterial Disease

Interventions

Aspirin; Heparin

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Thomas Davis, MD

  Ascension St John

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: October 31, 2019
• Primary Completion: December 1, 2019
• Study Completion: March 31, 2020
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

US (11)