Summary

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

Description

Summary

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

Keywords

Peripheral Arterial Disease Peripheral Vascular Diseases Atherectomy Catheter

Eligibility

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.

Locations

  • 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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Avinger, Inc.
ID
NCT03192696
Lead Scientist
Mitul Patel
Study Type
Interventional
Last Updated