Status:
WITHDRAWN
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)
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
EKOS Corporation
Conditions:
Chronic Total Occlusion
Atherosclerosis
Eligibility:
All Genders
25-80 years
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 CT...
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 guid...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04059536
Start Date
October 31 2019
End Date
March 31 2020
Last Update
July 21 2021
Active Locations (11)
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1
Dignity Health d/b/a St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States, 85013
2
Cardiovascular Research of North Florida LLC
Gainesville, Florida, United States, 32605
3
St. Mary Medical Center, Inc.
Hobart, Indiana, United States, 46342
4
MedStar Health Research Institute, Inc.
Hyattsville, Maryland, United States, 20782