Chronic Total Occlusion Crossing With the Wildcat Catheter

NCT01174784 | Completed Results

• 1 other identifier: AVI CTO 10001
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Peripheral Arterial Disease

Keywords

Chronic Total Occlusions; Superficial Femoral Artery; Popliteal Artery

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Treatment

EXPERIMENTAL

The Wildcat catheter is a CTO crossing catheter. Subjects will be subjected to crossing with this device.

Device: Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer

Interventions

Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer DEVICE

A Non-Randomized Study of the Avinger Wildcat™ used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries

Also known as: CONNECT

Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avinger, Inc.: lead

Study Sites (15)

Birmingham Heart Clinic

Birmingham, Alabama, 35235, United States

Location

Arizona Regional / Adventis

Mesa, Arizona, 85206, United States

Location

Phoenix Heart Center

Phoenix, Arizona, 85006, United States

Location

Sutter Memorial

Sacramento, California, 95619, United States

Location

Sharp Memorial

San Diego, California, 92123, United States

Location

Coastal Vascular

Pensacola, Florida, 32501, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Central Michigan Community Hospital

Mount Pleasant, Michigan, 48858, United States

Location

St. Louis University

St Louis, Missouri, 63110, United States

Location

Jobst Vascular Center

Toledo, Ohio, 43606, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Cardiology Care Consultants

El Paso, Texas, 79902, United States

Location

El Paso Cardiology Associates

El Paso, Texas, 79902, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Thomas Lawson, PhD
• Organization: Avinger Inc.

tlawson@avinger.com

650.241.7900

Study Officials

• Tom Davis, MD

  St. John Hospital

  PRINCIPAL INVESTIGATOR

• Laiq Raja, MD

  El Paso Cardiology Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 4, 2010
• Study Start: August 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 17, 2020
• Results First Posted: September 27, 2013

Record last verified: 2020-02

Locations

US (15)