Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries

Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - Any
Start Date:October 19, 2017
End Date:December 2020
Contact:Ruth Lira, BS

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

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- 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

- 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.
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