for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion
Mitul Patel, MD



A prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in lower extremity arteries.

Official Title

INSIGHT: EvaluatIoN of the PantheriS OCT- ImaGing AtHerectomy SysTem For Treatment of In-Stent Restenosis (ISR) Lesions In Lower Extremity Arteries


Peripheral Arterial Disease Peripheral Vascular Diseases Atherectomy Catheter


You can join if…

Open to people ages 18 years and up

  • Subject is >18 years old;
  • Subject is willing and able to give informed consent;
  • Subject has Rutherford Classification of I-V;
  • Subject presenting with a single Class I, II or III ISR lesion as per Tosaka's Classification criteria in the lower leg extremities;
  • Target lesion must be >70% stenosed and within a stented segment by angiographic visual estimation;
  • Reference vessel lumen acceptable for treatment with Pantheris catheter size as per visual angiographic estimation;
  • Target lesions must be within the stented segment and no more than 3 cm past the proximal or distal portions of the stent;
  • Target lesion is ≤30 cm in length;
  • Intraluminal crossing of totally occluded lesions prior to atherectomy;
  • At least one patent tibial run-off vessel at baseline; and
  • Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days, 6 months and 12 months.

You CAN'T join if...

  • Subject is pregnant or breast feeding;
  • Rutherford Class 0 or VI;
  • Severe calcification of the target lesion;
  • Acute ischemia and/or acute thrombosis of the target lesion segment;
  • Target lesion with a covered stent;
  • Target lesion in the iliac artery;
  • Target lesion stenosis <70%;
  • Target lesion >30 cm in length;
  • Subjects with totally occluded stented segments that are not successfully crossed intraluminally prior to atherectomy treatment;
  • Grade 4 or 5 stent fracture affecting target stent, or where evidence of stent protrusion into the lumen is noted on angiography in two orthogonal views;
  • Subjects on chronic hemodialysis or creatinine level >2.5 mg/dL;
  • CVA or stroke within 60 days prior to the index procedure;
  • 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;
  • Known allergy to contrast agents or medications used to perform endovascular
  • intervention that cannot be adequately pre-treated;
  • Subjects in whom anti-platelet, aspirin, anticoagulant, or thrombolytic therapy is contraindicated;
  • Any thrombolytic therapy within 2 weeks of the index procedure;
  • Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the study device into the subject during the index procedure;
  • Subjects or their legal guardians who have not or will not sign the Informed Consent;
  • Subjects who are unwilling or unable to comply with the follow-up study
  • requirements; or
  • 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.


  • University of California San Diego (UCSD) not yet accepting patients
    San Diego California 92037 United States
  • Phoenix Heart Center not yet accepting patients
    Phoenix Arizona 85006 United States

Lead Scientist


accepting new patients
Start Date
Completion Date
Avinger, Inc.
Study Type
Last Updated