Chronic Total Occlusion Crossing With the Wildcat Catheter (CONNECT)
This study has been completed.
Sponsor:
Avinger, Inc.
Information provided by (Responsible Party):
Avinger, Inc.
ClinicalTrials.gov Identifier:
NCT01174784
First received: August 2, 2010
Last updated: March 7, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral Arterial Disease |
Device: Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Non-randomized Study of the Avinger Wildcat Used to Cross Femoropopliteal CTOs |
Resource links provided by NLM:
Further study details as provided by Avinger, Inc.:
Primary Outcome Measures:
- Successful femoropopliteal CTO crossing using the Wildcat device as identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography. [ Time Frame: Day of Intervention ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Procedure success, defined as device success and the absence of in-hospital MAEs, clinically significant perforation, clinically significant embolization or Grade C or greater dissection. [ Time Frame: Day of Intervention and 30 day follow up ] [ Designated as safety issue: Yes ]
| Enrollment: | 88 |
| Study Start Date: | August 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Device: Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer
A Non-Randomized Study of the Avinger Wildcat™ used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries
Other Name: CONNECT
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174784
Locations
| United States, Alabama | |
| Birmingham Heart Clinic | |
| Birmingham, Alabama, United States, 35235 | |
| United States, Arizona | |
| Arizona Regional / Adventis | |
| Mesa, Arizona, United States, 85206 | |
| Phoenix Heart Center | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Sutter Memorial | |
| Sacramento, California, United States, 95619 | |
| Sharp Memorial | |
| San Diego, California, United States, 92123 | |
| United States, Florida | |
| Coastal Vascular | |
| Pensacola, Florida, United States, 32501 | |
| United States, Georgia | |
| Emory University Hospital | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Michigan | |
| St. John Hospital and Medical Center | |
| Detoit, Michigan, United States, 48236 | |
| Detroit Medical Center | |
| Detroit, Michigan, United States, 48201 | |
| Central Michigan Community Hospital | |
| Mount Pleasant, Michigan, United States, 48858 | |
| United States, Missouri | |
| St. Louis University | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Ohio | |
| Jobst Vascular Center | |
| Toledo, Ohio, United States, 43606 | |
| United States, Texas | |
| Austin Heart | |
| Austin, Texas, United States, 78756 | |
| Cardiology Care Consultants | |
| El Paso, Texas, United States, 79902 | |
| El Paso Cardiology Associates | |
| El Paso,, Texas, United States, 79902 | |
Sponsors and Collaborators
Avinger, Inc.
Investigators
| Principal Investigator: | Tom Davis, MD | St. John Hospital |
| Principal Investigator: | Laiq Raja, MD | El Paso Cardiology Associates |
More Information
No publications provided
| Responsible Party: | Avinger, Inc. |
| ClinicalTrials.gov Identifier: | NCT01174784 History of Changes |
| Other Study ID Numbers: | AVI CTO 10001 |
| Study First Received: | August 2, 2010 |
| Last Updated: | March 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Avinger, Inc.:
|
Chronic Total Occlusions Superficial Femoral Artery Popliteal Artery |
Additional relevant MeSH terms:
|
Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013