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JetStream Atherectomy for the Treatment of In-stent Restenosis (JET-ISR)

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ClinicalTrials.gov Identifier: NCT02730234
Recruitment Status : Completed
First Posted : April 6, 2016
Results First Posted : January 29, 2021
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Midwest Cardiovascular Research Foundation

Brief Summary:

The purpose of this study is to test the hypothesis that Jetstream atherectomy (JS) and adjunctive balloon angioplasty (PTA) (JS +PTA) improves target lesion revascularization (TLR) at 6 months follow-up when compared to historic data from PTA alone in the treatment of femoropopliteal (FP) arterial In-stent restenotic (ISR) disease.

This is a prospective, multicenter, single arm study evaluating the investigational use of Jetstream Atherectomy (JS) and adjunctive balloon angioplasty (JS +PTA) in the treatment of FP ISR lesions in subjects with claudication or limb ischemia (Rutherford clinical category (RCC) of 2-4) (lesion length ≥ 4 cm). The comparator arm is historic data from plain old balloon angioplasty derived from a Meta-analysis of the 3 published randomized trials in the field.


Condition or disease Intervention/treatment Phase
Femoropopliteal In-stent Restenosis Device: JetStream XC with balloon angioplasty Not Applicable

Detailed Description:

The Boston Scientific Jetstream XC catheter is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. The JS XC System has been cleared by the Food and Drug Administration (FDA) for use in the peripheral vasculature to treat denovo and non-stent infrainguinal lesions

Several studies have shown that stenting of the FP artery leads to higher long term patency. Bare metal stents however have not shown conclusively to reducemTLR which is in contrast to drug coated balloons (DCB) and drug coated stents (DCS). Irrespective, stenting has several disadvantages including a continued high rate of restenosis and stent fractures that is progressive with time. FP ISR occurs in more than one third of patients at 1 year and up to 49% at 2 years. Complex lesions (long, Trans-Atlantic Inter-Society Consensus II C/D lesions, total occlusions), certain demographics (female gender, diabetes mellitus), critical limb ischemia and significant stent fractures are associated with a higher rate of restenosis. Also the majority of occluded stents are restenotic-thrombotic and generally are more challenging to treat.

Recently 3 randomized trials were presented in treating FP ISR; the EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis (EXCITE ISR) trial (randomized laser + PTA vs PTA alone), the RELINE trial (Propaten Bioactive Surface vs. standard balloon angioplasty for treatment of in-stent restenosis in the superficial femoral artery) and the Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial. All these studies showed superiority over PTA in treating FP ISR. Early animal data (porcine model of FP ISR) and feasibility human data (JetStream ISR study) have shown that the JetStream device is effective in ablating restenotic tissue within restenotic FP stents and had no safety concerns within well apposed stents and in the absence of Class III and IV fractures.

The purpose of this study is to assess and estimate the effect of treating FP ISR with plaque excision using JS in combination with adjunctive PTA and compare this to historic control of PTA. The comparator arm is historic data from PTA derived from a study-level meta-analysis of the 3 published randomized trials in the field.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: JetStream Atherectomy for the Treatment of In-stent Restenosis of the Femoropopliteal Artery
Study Start Date : April 2016
Actual Primary Completion Date : February 4, 2020
Actual Study Completion Date : September 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: JetStream XC with balloon angioplasty
The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.
Device: JetStream XC with balloon angioplasty
JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.
Other Name: JetStream Navitus




Primary Outcome Measures :
  1. Percentage of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 6 months ]
    TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 6 months. For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered meeting a TLR endpoint. (ITT analysis)

  2. Major Adverse Events (MAE) [ Time Frame: 30 days ]
    unplanned major amputation, all cause mortality, and Bailout Stenting consider Target Lesion Revascularization (TLR).


Secondary Outcome Measures :
  1. Device Outcome [ Time Frame: Intraprocedural ]
    Categorized by < 50% residual stenosis following JS atherectomy alone and without additional adjunctive PTA or bail out procedures as determined by the Angiographic Core Laboratory.

  2. Procedural Success [ Time Frame: Intraprocedural ]
    Defined as ≤30% residual diameter stenosis following JS + PTA without provisional or bailout procedures

  3. Target Lesion Revascularization (TLR) With no Bailout Stent Included [ Time Frame: 6 months ]
    TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 6 months. Intra-procedural bail out stenting of the index lesion is NOT considered meeting a TLR endpoint. (ITT analysis)

  4. Target Lesion Revascularization (TLR) [ Time Frame: 1 year ]
    TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 1 year ITT (bail out stent in the Lab is not considered as TLR)

  5. Clinical Patency [ Time Frame: 6 months ]
    Defined as PSVR ≤ 2.5 at the treated site or < 50% stenosis by angiography as determined by the Angiographic Core Laboratory in the absence of TLR, amputation, and/or surgical bypass (the evaluation of patency is extended to one cm proximal and one cm distal to the target lesion)

  6. Clinical Patency [ Time Frame: 1 year ]
    Defined as PSVR ≤ 2.5 at the treated site or < 50% stenosis by angiography as determined by the Angiographic Core Laboratory in the absence of TLR, amputation, and/or surgical bypass (the evaluation of patency is extended to one cm proximal and one cm distal to the target lesion)

  7. Change in Walking Impairment Questionnaire Score [ Time Frame: Baseline and 6 months ]
    Defined as the change in mean Walking Impairment Questionnaire (WIQ) score at 6 months minus baseline. WIQ score range is 0 to 56. A higher score means a better outcome. WIQ is reported as a change between baseline and 6 months in the score (WIQ score at 6 months minus WIQ score at baseline)

  8. Rutherford Clinical Category [ Time Frame: 6 months ]
    Defined as the change in clinical status indicated by the number of participants that had one improvement of their Rutherford Becker category by at least 1 category at 6 months. The Rutherford category is done on a scale of 0 (no symptoms) to 6 (gangrene/ulceration). A change downward from one category to another is considered an improvement.

  9. Change in Ankle-Brachial Index [ Time Frame: 6 months ]
    Defined as the mean ankle-brachial index (ABI) at 6 months minus mean ABI at baseline in subjects with compressible arteries and baseline ABI < 0.9 (0 to 1.2 is the scale ranging from severe disease to normal respectively; higher is better).

  10. Change in Walking Impairment Questionnaire at 1 Year [ Time Frame: 1 Year ]

    Defined as the change in mean Walking Impairment Questionnaire (Score 0 to 56. A higher score means a better outcome) from Baseline minus at one Year.

    29.2-48.8 is the confidence interval minimum and maximum values.


  11. Rutherford Clinical Category [ Time Frame: 1 Year ]

    Defined as the change in clinical status indicated by the change in Rutherford Becker Class at 1 Year compared to baseline by at least one category that is attributable to the treated limb (in cases of bilateral disease).

    Categories are 0 which is asymptomatic to 6 which is gangrene. (Rutherford Becker Category:0=Asymptomatic, 1 = Mild Claudication, 2=moderated claudication, 3= severe claudication, 4= resting pain, 5= ulcers, 6= ulcers with gangrene.


  12. Ankle Brachial Index [ Time Frame: 1 Year ]
    Defined as the change in mean ankle-brachial index (ABI) at 1 Year minus mean ABI at baseline in subjects with compressible arteries and baseline ABI < 0.9. Units on a Scale: 0 to 1.2 (worse to normal respectively)

  13. Clinically Driven Target Lesion Revascularization [ Time Frame: 6 months ]
    Clinically-driven TLR (CD-TLR) at 6 months was defined as any reintervention or bypass graft surgery involving a target lesion with a ≥70% diameter stenosis by angiography or PSVR >3.5 and at least 2 of the following associated events: ≥1-level worsening of the Rutherford category, worsening WIQ score by ≥20 points, or an ABI drop >0.15 between baseline and follow-up.

  14. Clinically Driven Target Lesion Revascularization [ Time Frame: 12 months ]
    Clinically-driven TLR (CD-TLR) was defined as any reintervention or bypass graft surgery involving a target lesion with a ≥70% diameter stenosis by angiography or PSVR >3.5 and at least 2 of the following associated events: ≥1-level worsening of the Rutherford category, worsening WIQ score by ≥20 points, or an ABI drop >0.15 between baseline and follow-up.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with symptomatic peripheral arterial disease (Rutherford Becker Class II to IV)
  2. Previously treated with stenting in the femoropopliteal segment
  3. No limit on how many times the target in-stent restenotic lesion has been previously treated.
  4. There is no exclusion based on how the prior treatment was done including if drug eluting balloons or stents have been used. Covered stents cannot be included
  5. There is no limit on the length of the target lesion as long as only one target lesion is treated and enrolled

Exclusion Criteria:

Subjects must meet all of the following criteria to be eligible to participate in this study:

  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 2-4 and has symptoms of rest limb pain 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 > or = 5 mm and ≤ 7 mm
  7. One patent distal run-off vessel with <70% disease and with brisk flow is required.
  8. Intraluminal crossing of the lesion. If this is not certain, IVUS may be used to verify this per operator's discretion
  9. Patient has signed approved informed consent.
  10. Patient is willing to comply with the follow-up evaluations at specified times.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730234


Locations
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United States, Colorado
Eastern Colorado Healthcare System
Denver, Colorado, United States, 80220
United States, Florida
Florida Hospital Heartland Medical Center
Sebring, Florida, United States, 33872
United States, Illinois
Advocate Health
Downers Grove, Illinois, United States, 60515
United States, Iowa
Midwest Cardiovascular Research Foundation/Trinity Medical Center
Bettendorf, Iowa, United States, 52722
Midwest Cardiovascular Research Foundation/Genesis Medical Center
Davenport, Iowa, United States, 52722
United States, Louisiana
Endovascular Technologies, LLC
Shreveport, Louisiana, United States, 71103
United States, New Jersey
Atlantic Medical Imaging
Galloway, New Jersey, United States, 08205
United States, New Mexico
New Mexico Heart Institute
Albuquerque, New Mexico, United States, 87101
United States, Ohio
Promedica Toledo Hospital
Toledo, Ohio, United States, 43606
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
US Departmetn of Veterans Affairs, Oklahoma VA Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
VA North Texas Health Care System: Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Midwest Cardiovascular Research Foundation
Investigators
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Principal Investigator: Nicolas W Shammass, MD, MS Midwest Cardiovascular Research Foundation
Principal Investigator: Subhash Banerjee, MD VAMC, Dallas, Texas
  Study Documents (Full-Text)

Documents provided by Midwest Cardiovascular Research Foundation:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Midwest Cardiovascular Research Foundation
ClinicalTrials.gov Identifier: NCT02730234    
Other Study ID Numbers: MCRF-S-002-2015
First Posted: April 6, 2016    Key Record Dates
Results First Posted: January 29, 2021
Last Update Posted: January 29, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared in aggregate in a manuscript. No plan to share individual patient data