OptiCal COherence ToMography ABoard InformiNg AtherEctomy

NCT01775410 | Terminated Results

• 1 other identifier: P 0218
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, multi-center, non-randomized single arm feasibility trial of the Wolverine OCT guided atherectomy system.The trial will enroll up to 50 subjects diagnosed with peripheral vascular disease of the lower extremities.The primary disease must be located in reference vessel diameters ≥ 2.5 mm which is significant enough to cause moderate to severe symptoms and warrant vascular intervention.

Conditions

Atherectomy in Diseased Lower Extremity Arteries

Outcome Measures

Primary Outcomes (1)

• Number of Participants With no Major Adverse Events

  Freedom from major adverse events (MAE) through 30 day follow-up: * Clinically driven target lesion revascularization (TLR) * Myocardial infarct (MI) * Cardiovascular related deaths * Unplanned, major index limb amputation * Device Related Events: * Clinically Significant Perforations * Clinically Significant Dissections * Clinically Significant Embolus * Pseudoaneurysm

  Through 30 day follow-up

Secondary Outcomes (5)

• Technical Success: Percent of Target Lesions That Have a Residual Diameter Stenosis < 50%

  During interventional procedure

• Procedural Success: Percent of Target Lesions That Have Residual Diameter Stenosis ≤30% Post-Wolverine and Any Other Adjunctive Therapy

  Day 0

• Number of Participants With no Procedural Emboli

  During interventional procedure

• Ankle-Brachial Index (ABI) at 30 Days

  At 30 days

• Rutherford Classification at 30 Days Post-procedure

  At 30 days

Study Arms (1)

Wolverine System

EXPERIMENTAL

Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries

Device: Wolverine System to perform atherectomy

Interventions

Wolverine System to perform atherectomy DEVICE

Wolverine System

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Patient is a candidate for percutaneous intervention for peripheral vascular disease in the legs.
• Patient is willing and able to give informed consent
• Documented symptomatic atherosclerotic peripheral vascular disease Rutherford Classification 2-5.
• Reference vessel lumen proximal to target lesion \>2.5 mm in diameter by visual estimation.
• Subject has de novo target lesion(s) with stenosis \>70% by visual estimation distal to the profunda femoral artery. No more than 2 lesions may be treated with the Wolverine device.
• Target lesion length \<10 cm if target lesion \>70% and \<99% stenosed. If target lesion a chronic total occlusion (99-100% stenosed), target lesion length \<4 cm.
• Patient is capable of meeting requirements and be present at the follow-up clinic visits at 30 days.
• At least one patent tibial run-off vessel at baseline.

You may not qualify if:

• Subject is pregnant or breast feeding.
• Rutherford Class 0 to 1 (asymptomatic and mild claudication).
• Rutherford Class 6 (critical limb ischemia).
• Severe calcification of the target lesion.
• Target lesion with any type of stent or graft.
• Target lesion in the iliac artery.
• Target lesion stenosis \<70%.
• Subjects with significant (\>70%) occlusive lesions proximal to the target lesion not successfully treated during the index procedure (upstream disease) and prior to treatment of the target lesion.
• Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure.
• Planned endovascular or surgical procedure 30 days after the index procedure.
• Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure.
• Subjects with active infections whether they are being currently treated or not.
• Hemodialysis or GFR \<30 mL/min or creatinine level \>2.5mg/dL.
• Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
• Evidence or history of aneurysmal target vessel within the past 2 months.

Sponsors & Collaborators

• Avinger, Inc.: lead

Study Sites (2)

Angiografia de Occidente

Cali, VAC, Colombia

Location

Clinical Cardiovascular

Medellín, Colombia

Location

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Avinger, Inc.

tlawson@avinger.com

650 241 7030

Study Officials

• John B Simpson, MD

  Avinger, Inc.

  STUDY DIRECTOR

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: January 14, 2013
• First Posted: January 25, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 27, 2013
• Last Updated: April 21, 2021
• Results First Posted: April 21, 2021

Record last verified: 2021-04

Locations

CO (2)