Chronic Total Occlusion of Artery of the ExtremitiesCENTRALNCT01205386
Crosser Enters The Right Arterial Lumen
An observational study of Chronic Total Occlusion of Artery of the Extremities, run by C. R. Bard at 8 sites in United States.
Trial summary
The purpose of this study is to determine if the CROSSER CTO Recanalization System can facilitate the successful crossing of Chronic Total Occlusions in the Central lumen of the Superficial Femoral Artery (SFA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion of Artery of the Extremities
- What is being tested?
- 1. CROSSER System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2010to Aug 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CTO who are indicated for recanalization.
Who may be able to join
- Patient must have objective evidence of lower extremity ischemia and scheduled to undergo an endovascular recanalization.
- Occluded artery must be the native superficial femoral artery.
- Patient must have a totally occlusive lesion classified angiographically as absolute (100% occlusion with no flow).
- Patient's target vessel occlusion length is ≤ 30 cm.
- Patient's reference vessel diameter is greater than or equal to 3.0mm.
- Patient must be an acceptable candidate for PTA, peripheral artery bypass surgery or peripheral artery stent implantation.
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- Female patients of child bearing potential must have a negative pregnancy test within 72 hours prior to the study procedure.
- Patient or guardian must have been informed of the nature of the study, agree to its provisions, and provide written informed consent.
- Patient is ≥ 18 years of age.
Who cannot join
- Patient has hypersensitivity or contraindication to aspirin, heparin or radiographic contrast agents which cannot be adequately pre-medicated.
- The patient requires immediate treatment in more than one occluded vessel, in any combination of grafts or native vessels.
- Patient's occlusion is a flush occlusion initiating less than 2cm from the ostium.
- Patient has planned infrainguinal intervention scheduled within 30 days after index procedure.
- The patient is currently participating in another investigational drug or device trial that may conflict with study data collection and has not completed the entire follow-up period.
- Patient has no collateral flow distal to the occlusion.
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- Patient's target occlusion has a dissection that occurred within the past 60 days caused by a guidewire attempt.
- Patient has a history of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency.
- Patient suffered recent (within the past 6 months) stroke or transient ischemic neurological attack (TIA).
- Patient suffered recent (within the past 6 months) significant gastrointestinal (GI) bleeding.
- Patient has other medical illnesses (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with life-expectancy less than 1 year.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
The Christ Hospital
Cincinnati, Ohio, 45243
Mercy Heart and Vascular Center
Coon Rapids, Minnesota, 55433
Iowa Methodist Medical Center
Des Moines, Iowa, 50325
St. John Hospital and Medical Center
Detroit, Michigan, 48236
Memphis Heart Clinic
Memphis, Tennessee, 38120
Columbia University Medical Center
New York, New York, 10032
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Metro Health Hospital
Wyoming, Michigan, 49519
About this study
The purpose of this study is to determine if the CROSSER CTO Recanalization System can facilitate the successful crossing of Chronic Total Occlusions in the Central lumen of the Superficial Femoral Artery (SFA). A Chronic Total Occlusion (CTO) is defined as 100% narrowing of the artery, with no angiographically detectable antegrade blood flow, and the assessment that the lesion has been in existence for a minimum of 30 days. This study will enroll up to 100 patients at up to 8 clinical sites. The CROSSER CTO Recanalization System was cleared for commercialization by the US Food \& Drug Administration. This study also involves an imaging device called the IVUS (Intravascular Ultrasound Imaging) catheter. This device has been cleared for commercialization by the US Food and Drug Administration and will be studied for its cleared intended use. The IVUS catheter is used to generate real-time images of the artery, which will allow for evaluation of the artery after the occlusion is crossed. This is a post-market registry.
- Being tested
- 1. CROSSER System
- Keywords
- CTO, peripheral artery occlusive disease, PAOD, SFA, superficial femoral artery
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. CROSSER SystemDevice
Also called Crosser catheter, IVUS catheter
The Crosser system will be used to recanalize the chronic total occlusion in the SFA (superficial femoral artery). The IVUS (Intravascular Ultrasound Imaging) System will be used in the treated occlusion after the Crosser to generate real-time images of the artery.
| Study group | Role | What they receive |
|---|---|---|
| CROSSER | Not described Receives: Device: 1. CROSSER System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crosser navigates through the central lumen of the artery
Successful navigation of the CROSSER CTO Recanalization Catheter in the central lumen of the artery as confirmed by Intravascular Ultrasound (IVUS) following recanalization
Measured: At time of procedure (day 0)
Secondary outcomes (3)
Technical Success - crossing the CTO into the true distal lumen
The ability to facilitate crossing the CTO into the true distal lumen with the CROSSER Catheter and/or any conventional guidewire after use of the CROSSER.
Measured: At time of procedure (Day 0)
Procedural Success - Technical success plus residual stenosis < 50% and improved flow
Achievement of Technical Success plus a residual stenosis <50%, and improved flow verified angiographically, at the conclusion of the procedure.
Measured: Time of Procedure (Day 0)
Clinical Success - freedom from limb loss and repeat revascularization
Clinical Success - freedom from limb loss, and repeat revascularization (bypass surgery, or PTA) from index hospitalization through 6 moth follow-up
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Artery of the ExtremitiesStudies of the same condition, open and under way.
- More trials run by C. R. BardThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas P. Davis, MD, Principal investigator, St. John Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205386
- Sponsor's protocol ID
- CR1055-01
- Acronym
- CENTRAL
- Status last verified
- Sep 2012
- First submitted
- 26 Apr 2010
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crosser Enters The Right Arterial Lumen
- ClinicalTrials.gov ID
- NCT01205386
- Acronym / sponsor ID
- CENTRAL / CR1055-01
- Keywords
- CTO, peripheral artery occlusive disease, PAOD, SFA, superficial femoral artery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Sep 2010 (estimated)
- 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 study is to determine if the CROSSER CTO Recanalization System can facilitate the successful crossing of Chronic Total Occlusions in the Central lumen of the Superficial Femoral Artery (SFA). A Chronic Total Occlusion (CTO) is defined as 100% narrowing of the artery, with no angiographically detectable antegrade blood flow, and the assessment that the lesion has been in existence for a minimum of 30 days. This study will enroll up to 100 patients at up to 8 clinical sites. The CROSSER CTO Recanalization System was cleared for commercialization by the US Food \& Drug Administration. This study also involves an imaging device called the IVUS (Intravascular Ultrasound Imaging) catheter. This device has been cleared for commercialization by the US Food and Drug Administration and will be studied for its cleared intended use. The IVUS catheter is used to generate real-time images of the artery, which will allow for evaluation of the artery after the occlusion is crossed. This is a post-market registry.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CROSSER | – | Device: 1. CROSSER System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CTO who are indicated for recanalization.
Key inclusion criteria (9 listed)
- Patient must have objective evidence of lower extremity ischemia and scheduled to undergo an endovascular recanalization.
- Occluded artery must be the native superficial femoral artery.
- Patient must have a totally occlusive lesion classified angiographically as absolute (100% occlusion with no flow).
- Patient's target vessel occlusion length is ≤ 30 cm.
- Patient's reference vessel diameter is greater than or equal to 3.0mm.
Key exclusion criteria (11 listed)
- Patient has hypersensitivity or contraindication to aspirin, heparin or radiographic contrast agents which cannot be adequately pre-medicated.
- The patient requires immediate treatment in more than one occluded vessel, in any combination of grafts or native vessels.
- Patient's occlusion is a flush occlusion initiating less than 2cm from the ostium.
- Patient has planned infrainguinal intervention scheduled within 30 days after index procedure.
- The patient is currently participating in another investigational drug or device trial that may conflict with study data collection and has not completed the entire follow-up period.
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 |
|---|---|---|
| 1. CROSSER SystemAlso: Crosser catheter, IVUS catheterThe Crosser system will be used to recanalize the chronic total occlusion in the SFA (superficial femoral artery). The IVUS (Intravascular Ultrasound Imaging) System will be used in the treated occlusion after the Crosser to generate real-time images of the artery. | Device | CROSSER |
Primary outcome
Crosser navigates through the central lumen of the artery
Time frame: At time of procedure (day 0)
Successful navigation of the CROSSER CTO Recanalization Catheter in the central lumen of the artery as confirmed by Intravascular Ultrasound (IVUS) following recanalization
3 secondary outcomes
Technical Success - crossing the CTO into the true distal lumen
Time frame: At time of procedure (Day 0)
Procedural Success - Technical success plus residual stenosis < 50% and improved flow
Time frame: Time of Procedure (Day 0)
Clinical Success - freedom from limb loss and repeat revascularization
Time frame: 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
Related trials for Chronic Total Occlusion of Artery of the Extremities
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Recruiting
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Chronic Total Occlusion of Artery of the Extremities
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 P. Davis, MD principal investigator
St. John Hospital & Medical Center
8 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 of Artery of the Extremities, run by C. R. Bard at 8 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 11 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: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Crosser navigates through the central lumen of the artery (time frame: At time of procedure (day 0)). 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 10 Sep 2013.