Chronic Total Occlusion Crossing With the Wildcat Catheter

Peripheral Arterial Disease Clinical Trial

— CONNECT  

Official title:

A Non-randomized Study of the Avinger Wildcat Used to Cross Femoropopliteal CTOs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174784
• Other study ID #: AVI CTO 10001
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: February 2020
• Source: Avinger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Patient is willing and able to provide informed consent.

2. Patient is willing and able to comply with the study protocol.

3. Patient is > 18 years old.

4. Patient has peripheral arterial disease requiring revascularization as evidenced by contrast, CT or MR angiography.

5. Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is = 1 cm and = 30 cm in length by visual estimate.

6. Target femoropopliteal vessel is = 3.0 mm in diameter.

7. Patient has Rutherford Classification of 2-5.

Exclusion Criteria:

1. Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.

2. Patient has a known sensitivity or allergy to anti-platelet medications.

3. Patient is pregnant or lactating.

4. Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.

5. Target vessel is severely calcified as evidenced by angiography.

6. Target lesion is in a bypass graft.

7. Target lesion is in a stent (i.e., in-stent restenosis).

8. Patient has had a procedure on the target limb within 7 days.

9. Patient has had a procedure on the target limb within the past 30 days and is unstable.

10. Patient is simultaneously participating in an investigational device or drug study.

11. Patient has a planned surgical or interventional procedure within 30 days after the study procedure.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Austin Heart	Austin	Texas
United States	Birmingham Heart Clinic	Birmingham	Alabama
United States	Detroit Medical Center	Detroit	Michigan
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	Cardiology Care Consultants	El Paso	Texas
United States	El Paso Cardiology Associates	El Paso	Texas
United States	Arizona Regional / Adventis	Mesa	Arizona
United States	Central Michigan Community Hospital	Mount Pleasant	Michigan
United States	Coastal Vascular	Pensacola	Florida
United States	Phoenix Heart Center	Phoenix	Arizona
United States	Sutter Memorial	Sacramento	California
United States	St. Louis University	Saint Louis	Missouri
United States	Sharp Memorial	San Diego	California
United States	Jobst Vascular Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Avinger, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Index through 30-Day Follow-Up
Primary	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.	Index through 30-Day Follow-Up