JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions

Not Applicable

Completed

Conditions: Restenosis
Peripheral Vascular Disease

Interventions: Device: JetStream Navitus

Registration Number: NCT01722877

Lead Sponsor: Midwest Cardiovascular Research Foundation

Brief Summary: Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone. However, scar tissue development can occur within the stent, a process called restenosis. Treatment of these in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue is frequently seen. Several methods have been proposed to treat in-stent restenosis in the lower leg arteries but mixed results have been noted. In this study we hypothesize that simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can lead to a high rate of acute procedural success with low intraprocedural complications and an acceptable recurrence rate of restenosis at 6-month follow-up.

Detailed Description: Data not available yet.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 29

Inclusion Criteria

Subject is 18 years of age or older.
Subject presents with clinical evidence of peripheral arterial disease with ISR in the femoropopliteal segment (includes common femoral, superficial femoral and popliteal)
Subject presents with a Rutherford Classification of 1-5 and has symptoms of rest limb pain, ulcerations or claudication.
Target lesion(s) must be viewed angiographically and have ≥50% stenosis.
The atherectomy wire must be placed entirely across all lesions to be treated with no visible evidence of clear or suspected subintimal/substent wire passage.
The main target vessel reference diameter must be at least 5 mm.
One patent distal run-off vessel with brisk flow is required.
Patient is an acceptable candidate for percutaneous intervention using the Jetstream NAVITUS System in accordance with its labeled instructions for use.
Patient has signed approved informed consent.
Patient is willing to comply with the follow-up evaluations at specified times.

Exclusion Criteria

Subject is unable to understand the study or has a history of non-compliance with medical advice.
Subject is unwilling or unable to sign the Informed Consent Form (ICF).
Subject is currently enrolled in another clinical investigational study that might clinically interfere with the current study endpoints (e.g., limit use of study-recommended medications, etc.).
Subject is pregnant or planning to become pregnant within the study period.
Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated for.
Subject is diagnosed with chronic renal failure or has a creatinine level > 2.5 mg/dl and is not on chronic dialysis.
Subject has a known allergy to heparin, ASA, Plavix.
Subject has a history of bleeding disorders or platelet count < 80,000 cells/ml.
Subject experiences ongoing cardiac problems (e.g., cardiac arrhythmias, congestive heart failure exacerbation, myocardial infarction, etc.) that, per the investigator, would not make the subject an ideal candidate for study procedures.
Subject has a CVA or TIA within 4 weeks prior to JetStream procedure.
Subject has an anticipated life span of less than 6 months.
Subject is suspected of having an active systemic infection.
Subject per the investigator's medical judgment must be excluded from the study.
Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s).
Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
Patient has any planned surgical intervention or endovascular procedure within 15 days after the index procedure.
Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System.
Use of another debulking device after the Jetstream NAVITUS system.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JetStream Atherectomy	JetStream Navitus	Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature.

Primary Outcome Measures

Name	Time	Method
Acute Procedural Success	intraprocedural	Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.

Secondary Outcome Measures

Name	Time	Method
Target Lesion Revascularization	6 months	Reintervention on the same index lesion at 6 months
Patency	6 months	Patency is defined as Peak Systolic Velocity Ratio (PSVR) of \< 2.4 by duplex criteria. PSVR is obtained by dividing velocity (cm/sec) at the lesion site to the velocity immediately proximal to the lesion.