Clinical trial NCT01722877: JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions
Official title: Safety and Effectiveness of JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions: A Prospective Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restenosis
Peripheral Vascular Disease
Keywords: Restenosis
aspiration
in-stent restenosis
atherectomy
superficial femoral artery
popliteal artery
Lead sponsor: Midwest Cardiovascular Research Foundation
Sponsor class: OTHER
Collaborators: name: MEDRAD, Inc.
First posted: 2012-11-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Subject is 18 years of age or older.
2. Subject presents with clinical evidence of peripheral arterial disease with ISR in the femoropopliteal segment (includes common femoral, superficial femoral and popliteal)
3. Subject presents with a Rutherford Classification of 1-5 and has symptoms of rest limb pain, ulcerations or claudication.
4. Target lesion(s) must be viewed angiographically and have ≥50% stenosis.
5. 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.
6. The main target vessel reference diameter must be at least 5 mm.
7. One patent distal run-off vessel with brisk flow is required.
8. Patient is an acceptable candidate for percutaneous intervention using the Jetstream NAVITUS System in accordance with its labeled instructions for use.
9. Patient has signed approved informed consent.
10. Patient is willing to comply with the follow-up evaluations at specified times.

Exclusion Criteria:

1. Subject is unable to understand the study or has a history of non-compliance with medical advice.
2. Subject is unwilling or unable to sign the Informed Consent Form (ICF).
3. 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.).
4. Subject is pregnant or planning to become pregnant within the study period.
5. Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated for.
6. Subject is diagnosed with chronic renal failure or has a creatinine level \> 2.5 mg/dl and is not on chronic dialysis.
7. Subject has a known allergy to heparin, ASA, Plavix.
8. Subject has a history of bleeding disorders or platelet count \< 80,000 cells/ml.
9. 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.
10. Subject has a CVA or TIA within 4 weeks prior to JetStream procedure.
11. Subject has an anticipated life span of less than 6 months.
12. Subject is suspected of having an active systemic infection.
13. Subject per the investigator's medical judgment must be excluded from the study.
14. Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s).
15. Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
16. Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
17. Patient has any planned surgical intervention or endovascular procedure within 15 days after the index procedure.
18. Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System.
19. Use of another debulking device after the Jetstream NAVITUS system.

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Primary outcomes:
measure: Acute Procedural Success
timeFrame: intraprocedural
Secondary outcomes:
measure: Patency
timeFrame: 6 months
measure: Target Lesion Revascularization
timeFrame: 6 months
Other outcomes:
measure: Acute Device Success
timeFrame: intraprocedural
Locations:
city: Bettendorf
country: United States
facility: Trinity Bettendorf Medical Center
state: Iowa
city: Dallas
country: United States
facility: VA Medical Center
state: Texas
Study officials:
affiliation: Midwest Cardiovascular Research Foundation
name: Nicolas W Shammas, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shammas NW, Shammas GA, Banerjee S, Popma JJ, Mohammad A, Jerin M. JetStream Rotational and Aspiration Atherectomy in Treating In-Stent Restenosis of the Femoropopliteal Arteries: Results of the JETSTREAM-ISR Feasibility Study. J Endovasc Ther. 2016 Apr;23(2):339-46. doi: 10.1177/1526602816634028. Epub 2016 Feb 26.