OptiCal COherence ToMography ABoard InformiNg AtherEctomy (COMBINE)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Avinger, Inc.
ClinicalTrials.gov Identifier:
NCT01775410
First received: January 14, 2013
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Atherectomy in Diseased Lower Extremity Arteries.
Device: Wolverine System to perform atherectomy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Non-randomized, Multi-center Feasibility Trial of the Avinger Wolverine System, an Atherectomy Device That Provides Directional Visualization and Imaging While Removing Plaque in Diseased Lower Extremity Arteries

Resource links provided by NLM:


Further study details as provided by Avinger, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: Through 30 day follow-up ] [ Designated as safety issue: Yes ]

    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


Secondary Outcome Measures:
  • Effectiveness [ Time Frame: During interventional procedure ] [ Designated as safety issue: No ]
    Technical success is defined as the percent of target lesions that has a residual diameter stenosis < 50% post the Wolverine device alone as assessed by an independent review at the time of treatment using quantitative angiography or visual estimate


Other Outcome Measures:
  • Secondary Safety Endpoint [ Time Frame: During interventional procedure ] [ Designated as safety issue: Yes ]
    Freedom from procedural emboli, defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator

  • Secondary Effectiveness Endpoints [ Time Frame: At 30 days ] [ Designated as safety issue: No ]
    • Procedural success defined as the percent of target lesions that have residual diameter stenosis ≤30% post-Wolverine and any other adjunctive therapy.

  • Secondary Effectiveness Endpoints [ Time Frame: At 30 days ] [ Designated as safety issue: No ]
    Ankle-Brachial Index at 30 days

  • Secondary Effectiveness Endpoints [ Time Frame: At 30 days ] [ Designated as safety issue: No ]
    Rutherford Classification at 30 days.


Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: September 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventional
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old.
  2. Patient is a candidate for percutaneous intervention for peripheral vascular disease in the legs.
  3. Patient is willing and able to give informed consent
  4. Documented symptomatic atherosclerotic peripheral vascular disease Rutherford Classification 2-5.
  5. Reference vessel lumen proximal to target lesion >2.5 mm in diameter by visual estimation.
  6. 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.
  7. 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.
  8. Patient is capable of meeting requirements and be present at the follow-up clinic visits at 30 days.
  9. At least one patent tibial run-off vessel at baseline.

Exclusion Criteria:

  1. Subject is pregnant or breast feeding.
  2. Rutherford Class 0 to 1 (asymptomatic and mild claudication).
  3. Rutherford Class 6 (critical limb ischemia).
  4. Severe calcification of the target lesion.
  5. Target lesion with any type of stent or graft.
  6. Target lesion in the iliac artery.
  7. Target lesion stenosis <70%.
  8. 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.
  9. Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure.
  10. Planned endovascular or surgical procedure 30 days after the index procedure.
  11. Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure.
  12. Subjects with active infections whether they are being currently treated or not.
  13. Hemodialysis or GFR <30 mL/min or creatinine level >2.5mg/dL.
  14. Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
  15. Evidence or history of aneurysmal target vessel within the past 2 months.
  16. History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
  17. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
  18. Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated.
  19. History of heparin-induced thrombocytopenia (HIT).
  20. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2 , known coagulopathy, or INR >1.5.
  21. Any thrombolytic therapy within 2 weeks of the index procedure.
  22. Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the Wolverine into the subject.
  23. Subjects or their legal guardians who have not or will not sign the Informed Consent.
  24. Subjects who are unwilling or unable to comply with the follow-up study requirements.
  25. Participation in any study of an investigational device, medication, biologic or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775410

Locations
Colombia
Angiografia de Occidente
Cali, VAC, Colombia
Clinical Cardiovascular
Medellin, Colombia
Sponsors and Collaborators
Avinger, Inc.
  More Information

No publications provided

Responsible Party: Avinger, Inc.
ClinicalTrials.gov Identifier: NCT01775410     History of Changes
Other Study ID Numbers: P 0218
Study First Received: January 14, 2013
Last Updated: September 11, 2014
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Colombia: National Institutes of Health

ClinicalTrials.gov processed this record on October 21, 2014