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

Safety and Effectiveness of JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions: A Prospective Registry

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease; Restenosis
• Intervention / Treatment: Device: JetStream Navitus

Detailed Description

Data not available yet.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Bettendorf, Iowa, United States, 52722
      • Trinity Bettendorf Medical Center
  • Texas
    • Dallas, Texas, United States
      • VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JetStream Atherectomy; Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature.	Device: JetStream Navitus; Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Procedural Success	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.	intraprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patency	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.	6 months
Target Lesion Revascularization	Reintervention on the same index lesion at 6 months	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Device Success	Acute device success is defined as less than or equal to 50% residual stenosis at the index lesion using the JetStream device alone and with no adjunctive balloon angioplasty therapy (via Quantitative Vascular Analysis) and with no serious adverse events.	intraprocedural

Collaborators and Investigators

• Sponsor: Midwest Cardiovascular Research Foundation
• Collaborators: MEDRAD, Inc.
• Investigators: Principal Investigator: Nicolas W Shammas, MD, MS, Midwest Cardiovascular Research Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: November 5, 2012
• First Submitted That Met QC Criteria: November 5, 2012
• First Posted (Estimate): November 7, 2012

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: atherectomy; Restenosis; aspiration; in-stent restenosis; superficial femoral artery; popliteal artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: JS-ISR-001, version 1, Rev 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Manuscript will be published in JEVT early 2016