Peripheral Arterial DiseaseCONNECTNCT01174784
Chronic Total Occlusion Crossing With the Wildcat Catheter
A study testing Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer in people with Peripheral Arterial Disease, run by Avinger, Inc. at 15 sites in United States.
Trial summary
This is a prospective, multi-center, non-randomized study of the Wildcat Catheter to cross a single femoropopliteal chronic total occlusion (CTO). Safety and efficacy will be evaluated during the index procedure through 30-day follow-up. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 15 sitesUnited States
- Study dates
- Aug 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is willing and able to provide informed consent.
- Patient is willing and able to comply with the study protocol.
- Patient is > 18 years old.
- Patient has peripheral arterial disease requiring revascularization as evidenced by contrast, CT or MR angiography.
- Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate.
- Target femoropopliteal vessel is ≥ 3.0 mm in diameter.
- Patient has Rutherford Classification of 2-5.
Who cannot join
- Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
- Patient has a known sensitivity or allergy to anti-platelet medications.
- Patient is pregnant or lactating.
- Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
- Target vessel is severely calcified as evidenced by angiography.
- Target lesion is in a bypass graft.
Show all 11Show fewer
- Target lesion is in a stent (i.e., in-stent restenosis).
- Patient has had a procedure on the target limb within 7 days.
- Patient has had a procedure on the target limb within the past 30 days and is unstable.
- Patient is simultaneously participating in an investigational device or drug study.
- Patient has a planned surgical or interventional procedure within 30 days after the study procedure.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Emory University Hospital
Atlanta, Georgia, 30308
Austin Heart
Austin, Texas, 78756
Birmingham Heart Clinic
Birmingham, Alabama, 35235
Detroit Medical Center
Detroit, Michigan, 48201
St. John Hospital and Medical Center
Detroit, Michigan, 48236
Cardiology Care Consultants
El Paso, Texas, 79902
El Paso Cardiology Associates
El Paso, Texas, 79902
Arizona Regional / Adventis
Mesa, Arizona, 85206
Central Michigan Community Hospital
Mount Pleasant, Michigan, 48858
Coastal Vascular
Pensacola, Florida, 32501
Phoenix Heart Center
Phoenix, Arizona, 85006
Sutter Memorial
Sacramento, California, 95619
Sharp Memorial
San Diego, California, 92123
St. Louis University
St Louis, Missouri, 63110
Jobst Vascular Center
Toledo, Ohio, 43606
About this study
Official title: A Non-randomized Study of the Avinger Wildcat Used to Cross Femoropopliteal CTOs
This is a prospective, multi-center, non-randomized study of the Wildcat Catheter to cross a single femoropopliteal chronic total occlusion (CTO). Safety and efficacy will be evaluated during the index procedure through 30-day follow-up.
Read the detailed description
Patients with a CTO, defined as 99% to 100% stenosis of a peripheral artery, will be approached for enrollment in the study. Following providing informed consent, the CTO will be addressed by the Wildcat catheter, which will provide a route for the advancement of guidewires and other tools beyond the CTO. Data will be collected to assess the safety efficacy of use of the device during the procedure and up to 30 days post-procedure.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer
- Keywords
- Chronic Total Occlusions, Superficial Femoral Artery, Popliteal Artery
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTerDevice
Also called CONNECT
A Non-Randomized Study of the Avinger Wildcat™ used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The Wildcat catheter is a CTO crossing catheter. Subjects will be subjected to crossing with this device. Receives: Device: Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Events
The primary safety endpoint of the CONNECT Study was defined as absence of in-hospital or 30-days Major Adverse Events (MAEs), no evidence of clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Wildcat CTO crossing confirmed by angiography.
Measured: Index through 30-Day Follow-Up
CTO Crossing Success Using the Wildcat
Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography.
Measured: Index through 30-Day Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avinger, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Davis, MD, Principal investigator, St. John HospitalLaiq Raja, MD, Principal investigator, El Paso Cardiology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174784
- Sponsor's protocol ID
- AVI CTO 10001
- Acronym
- CONNECT
- Status last verified
- Feb 2020
- First submitted
- 2 Aug 2010
- Last updated
- 17 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized Study of the Avinger Wildcat Used to Cross Femoropopliteal CTOs
- ClinicalTrials.gov ID
- NCT01174784
- Acronym / sponsor ID
- CONNECT / AVI CTO 10001
- Conditions
- Peripheral Arterial Disease
- Keywords
- Chronic Total Occlusions, Superficial Femoral Artery, Popliteal Artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Avinger, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Aug 2010 (estimated)
- Results
- Posted 27 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center, non-randomized study of the Wildcat Catheter to cross a single femoropopliteal chronic total occlusion (CTO). Safety and efficacy will be evaluated during the index procedure through 30-day follow-up.
Detailed description
Patients with a CTO, defined as 99% to 100% stenosis of a peripheral artery, will be approached for enrollment in the study. Following providing informed consent, the CTO will be addressed by the Wildcat catheter, which will provide a route for the advancement of guidewires and other tools beyond the CTO. Data will be collected to assess the safety efficacy of use of the device during the procedure and up to 30 days post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTerThe Wildcat catheter is a CTO crossing catheter. Subjects will be subjected to crossing with this device. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is willing and able to provide informed consent.
- Patient is willing and able to comply with the study protocol.
- Patient is > 18 years old.
- Patient has peripheral arterial disease requiring revascularization as evidenced by contrast, CT or MR angiography.
- Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate.
Key exclusion criteria (11 listed)
- Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
- Patient has a known sensitivity or allergy to anti-platelet medications.
- Patient is pregnant or lactating.
- Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
- Target vessel is severely calcified as evidenced by angiography.
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 |
|---|---|---|
| Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTerAlso: CONNECTA Non-Randomized Study of the Avinger Wildcat™ used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries | Device | Treatment |
Primary outcome
Major Adverse Events
Time frame: Index through 30-Day Follow-Up
The primary safety endpoint of the CONNECT Study was defined as absence of in-hospital or 30-days Major Adverse Events (MAEs), no evidence of clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Wildcat CTO crossing confirmed by angiography.
CTO Crossing Success Using the Wildcat
Time frame: Index through 30-Day Follow-Up
Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tom Davis, MD principal investigator
St. John Hospital
Laiq Raja, MD principal investigator
El Paso Cardiology Associates
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer in people with Peripheral Arterial Disease, run by Avinger, Inc. at 15 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 7 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 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Yes. Results are posted in the registry (first posted 27 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Major Adverse Events (time frame: Index through 30-Day Follow-Up). 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 17 Jul 2020.