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)
Withdrawn before enrolling
Conditions studied: Chronic Total Occlusion, Atherosclerosis, Coronary Artery Disease, Peripheral Artery Disease
In brief
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.
Key facts
- Study ID
- NCT04059536
- Run by
- Boston Scientific Corporation
- People needed
- 0
- Starts
- 2019-10-31
- Expected to finish
- 2020-03-31
- Last updated by the study team
- 2021-07-21
Who can join
Age: 25 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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
- 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
Where it is running
- Dignity Health d/b/a St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States
- Cardiovascular Research of North Florida LLC — Gainesville, Florida, United States
- St. Mary Medical Center, Inc. — Hobart, Indiana, United States
- MedStar Health Research Institute, Inc. — Hyattsville, Maryland, United States
- Ascension St. John Hospital — Detroit, Michigan, United States
- McLaren Healthcare Corporation — Flint, Michigan, United States
- McLaren Healthcare Corporation — Grand Blanc, Michigan, United States
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
- Columbia University — New York, New York, United States
- WellSpan Health Corporation — York, Pennsylvania, United States
- The Miriam Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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