Clinical trial NCT02730234: JetStream Atherectomy for the Treatment of In-stent Restenosis
Official title: JetStream Atherectomy for the Treatment of In-stent Restenosis of the Femoropopliteal Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoropopliteal In-stent Restenosis
Lead sponsor: Midwest Cardiovascular Research Foundation
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 60
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: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Target Lesion Revascularization (TLR)
timeFrame: 6 months
measure: Major Adverse Events (MAE)
timeFrame: 30 days
Secondary outcomes:
measure: Device Outcome
timeFrame: Intraprocedural
measure: Procedural Success
timeFrame: Intraprocedural
measure: Target Lesion Revascularization (TLR) With no Bailout Stent Included
timeFrame: 6 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 1 year
measure: Clinical Patency
timeFrame: 6 months
measure: Clinical Patency
timeFrame: 1 year
measure: Change in Walking Impairment Questionnaire Score
timeFrame: Baseline and 6 months
measure: Number of Participants With Rutherford Clinical Category Improvement
timeFrame: 6 months
measure: Change in Ankle-Brachial Index
timeFrame: 6 months
measure: Change in Walking Impairment Questionnaire at 1 Year
timeFrame: 1 Year
measure: Rutherford Clinical Category
timeFrame: 1 Year
measure: Ankle Brachial Index
timeFrame: 1 Year
measure: Clinically Driven Target Lesion Revascularization
timeFrame: 6 months
measure: Clinically Driven Target Lesion Revascularization
timeFrame: 12 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Eastern Colorado Healthcare System
state: Colorado
city: Sebring
country: United States
facility: Florida Hospital Heartland Medical Center
state: Florida
city: Downers Grove
country: United States
facility: Advocate Health
state: Illinois
city: Bettendorf
country: United States
facility: Midwest Cardiovascular Research Foundation/Trinity Medical Center
state: Iowa
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation/Genesis Medical Center
state: Iowa
city: Shreveport
country: United States
facility: Endovascular Technologies, LLC
state: Louisiana
city: Galloway
country: United States
facility: Atlantic Medical Imaging
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: Toledo
country: United States
facility: Promedica Toledo Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: US Departmetn of Veterans Affairs, Oklahoma VA Medical Center
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: VA North Texas Health Care System: Dallas VA Medical Center
state: Texas
Study officials:
affiliation: Midwest Cardiovascular Research Foundation
name: Nicolas W Shammass, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: VAMC, Dallas, Texas
name: Subhash Banerjee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shammas NW, Aasen N, Bailey L, Budrewicz J, Farago T, Jarvis G. Two Blades-Up Runs Using the JetStream Navitus Atherectomy Device Achieve Optimal Tissue Debulking of Nonocclusive In-Stent Restenosis: Observations From a Porcine Stent/Balloon Injury Model. J Endovasc Ther. 2015 Aug;22(4):518-24. doi: 10.1177/1526602815592135. Epub 2015 Jun 24.
citation: Krankenberg H, Tubler T, Ingwersen M, Schluter M, Scheinert D, Blessing E, Sixt S, Kieback A, Beschorner U, Zeller T. Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial. Circulation. 2015 Dec 8;132(23):2230-6. doi: 10.1161/CIRCULATIONAHA.115.017364. Epub 2015 Oct 7.
citation: Beschorner U, Krankenberg H, Scheinert D, Sievert H, Tubler T, Sixt S, Noory E, Rastan A, Macharzina R, Zeller T. Rotational and aspiration atherectomy for infrainguinal in-stent restenosis. Vasa. 2013 Mar;42(2):127-33. doi: 10.1024/0301-1526/a000256.
citation: Shammas NW, Shammas GA, Aasen N, Jarvis G. Number of Blades-up Runs Using JetStream XC Atherectomy for Optimal Tissue Debulking in Patients with Femoropopliteal Artery In-Stent Restenosis. J Vasc Interv Radiol. 2015 Dec;26(12):1847-51. doi: 10.1016/j.jvir.2015.08.026.
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.
citation: Bosiers M, Deloose K, Callaert J, Verbist J, Hendriks J, Lauwers P, Schroe H, Lansink W, Scheinert D, Schmidt A, Zeller T, Beschorner U, Noory E, Torsello G, Austermann M, Peeters P. Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial. J Endovasc Ther. 2015 Feb;22(1):1-10. doi: 10.1177/1526602814564385.
citation: Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, Mena-Hurtado C, Beasley R, Soukas P, Colon-Hernandez PJ, Stark MA, Walker C; EXCITE ISR Investigators. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):92-101. doi: 10.1016/j.jcin.2014.09.009. Epub 2014 Dec 10.
citation: Shammas NW. JETSTREAM Atherectomy: A Review of Technique, Tips, and Tricks in Treating the Femoropopliteal Lesions. Int J Angiol. 2015 Jun;24(2):81-6. doi: 10.1055/s-0034-1390083.
citation: Shammas NW, Petruzzi N, Henao S, Armstrong EJ, Shimshak T, Banerjee S, Latif F, Eaves B, Brothers T, Golzar J, Shammas GA, Jones-Miller S, Christensen L, Shammas WJ. JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study. J Endovasc Ther. 2021 Feb;28(1):107-116. doi: 10.1177/1526602820951916. Epub 2020 Sep 4.