Coronary Artery Disease Clinical Trial
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)
Verified date | July 2021 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 31, 2020 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ascension St. John Hospital | Detroit | Michigan |
United States | McLaren Healthcare Corporation | Flint | Michigan |
United States | Cardiovascular Research of North Florida LLC | Gainesville | Florida |
United States | McLaren Healthcare Corporation | Grand Blanc | Michigan |
United States | St. Mary Medical Center, Inc. | Hobart | Indiana |
United States | MedStar Health Research Institute, Inc. | Hyattsville | Maryland |
United States | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota |
United States | Columbia University | New York | New York |
United States | Dignity Health d/b/a St. Joseph's Hospital & Medical Center | Phoenix | Arizona |
United States | The Miriam Hospital | Providence | Rhode Island |
United States | WellSpan Health Corporation | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation | EKOS Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | 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 | |
Secondary | Number of Participants Without Contrast Induced Renal Failure | 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 | |
Secondary | Time From the Roxwood Medical Device Insertion to Penetration of the Stenotic Lesion or Proximal Cap | 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 | |
Secondary | Time From the Roxwood Medical Device to Cross the True Lumen Distally | 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 |
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