Chronic Total OcclusionNCT04059536
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)
An observational study of Chronic Total Occlusion and Atherosclerosis, run by Boston Scientific Corporation at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Chronic Total Occlusion, Atherosclerosis, Coronary Artery Disease
- What is being tested?
- Roxwood Anchoring Catheters, Acetylsalicylic Acid and Heparin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 0 participants
- Where
- 11 sitesUnited States
- Study dates
- 31 Oct 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- Adult aged 25 - 80
- Participant understands and has signed the study informed consent form
- Left ventricle ejection fraction >25% (coronary enrollments only)
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Ascension St. John Hospital
Detroit, Michigan, 48236
McLaren Healthcare Corporation
Flint, Michigan, 48501
Cardiovascular Research of North Florida LLC
Gainesville, Florida, 32605
McLaren Healthcare Corporation
Grand Blanc, Michigan, 48439
St. Mary Medical Center, Inc.
Hobart, Indiana, 46342
MedStar Health Research Institute, Inc.
Hyattsville, Maryland, 20782
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Columbia University
New York, New York, 10032
Dignity Health d/b/a St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
The Miriam Hospital
Providence, Rhode Island, 02906
WellSpan Health Corporation
York, Pennsylvania, 17403
About this study
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)
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.
Read the 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.
- Conditions
- Chronic Total Occlusion, Atherosclerosis, Coronary Artery Disease, Peripheral Artery Disease
- Being tested
- Roxwood Anchoring Catheters, Acetylsalicylic Acid, Heparin
- Keywords
- Stenotic Lesions
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roxwood Anchoring CathetersDevice
Also called 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
Anchoring catheters
Acetylsalicylic AcidDrug
Also called Aspirin
Oral Tablet
HeparinDrug
Intravenous Injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Roxwood Anchoring Catheters; Drug: Acetylsalicylic Acid; Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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]).
Measured: 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
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.
Measured: Index Procedure (Day 0) up to Day 30 Post Procedure
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.
Measured: Baseline up to 24 hours post procedure
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.
Measured: Day 0
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start31 Oct 2019 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total OcclusionStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EKOS Corporation
- Responsible party
- Sponsor
- Investigators
- Thomas Davis, MD, Principal investigator, Ascension St. John
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059536
- Sponsor's protocol ID
- BTG-007927-01
- Status last verified
- Jul 2021
- First submitted
- 14 Aug 2019
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04059536
- Acronym / sponsor ID
- BTG-007927-01
- Conditions
- Chronic Total Occlusion, Atherosclerosis, Coronary Artery Disease, Peripheral Artery Disease
- Keywords
- Stenotic Lesions
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- EKOS Corporation
- Study start
- 31 Oct 2019 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roxwood Anchoring Catheters | – | Device: Roxwood Anchoring Catheters, Drug: Acetylsalicylic Acid, Drug: HeparinParticipants 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. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roxwood Anchoring CathetersAlso: 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 lengthAnchoring catheters | Device | Roxwood Anchoring Catheters |
| Acetylsalicylic AcidAlso: AspirinOral Tablet | Drug | Roxwood Anchoring Catheters |
| HeparinIntravenous Injection | Drug | Roxwood Anchoring Catheters |
Primary outcome
Number of Participants with a Successful Index Procedure by Roxwood Medical Device(s)
Time frame: Index Procedure (Day 0) to 24 hours Post Procedure
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.
Number of Participants Without an Index Procedure Related Safety Incident Related to the Roxwood Medical Device
Time frame: Index Procedure (Day 0) to 24 hours Post Procedure
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]).
4 secondary outcomes
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
Time frame: Index Procedure (Day 0) up to Day 30 Post Procedure
Number of Participants Without Contrast Induced Renal Failure
Time frame: Baseline up to 24 hours post procedure
Time From the Roxwood Medical Device Insertion to Penetration of the Stenotic Lesion or Proximal Cap
Time frame: Day 0
Time From the Roxwood Medical Device to Cross the True Lumen Distally
Time frame: Day 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Davis, MD principal investigator
Ascension St. John
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Total Occlusion and Atherosclerosis, run by Boston Scientific Corporation at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with a Successful Index Procedure by Roxwood Medical Device(s) (time frame: Index Procedure (Day 0) to 24 hours Post Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.