JetStream Atherectomy for the Treatment of In-stent Restenosis

Femoropopliteal In-stent Restenosis Clinical Trial

— JET-ISR  

Official title:

JetStream Atherectomy for the Treatment of In-stent Restenosis of the Femoropopliteal Artery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730234
• Other study ID #: MCRF-S-002-2015
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: September 24, 2020

Study information

• Verified date: October 2020
• Source: Midwest Cardiovascular Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 24, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Femoropopliteal In-stent Restenosis

Intervention

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.

Locations

Country	Name	City	State
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	Midwest Cardiovascular Research Foundation/Trinity Medical Center	Bettendorf	Iowa
United States	Medical University of South Carolina	Charleston	South Carolina
United States	VA North Texas Health Care System: Dallas VA Medical Center	Dallas	Texas
United States	Midwest Cardiovascular Research Foundation/Genesis Medical Center	Davenport	Iowa
United States	Eastern Colorado Healthcare System	Denver	Colorado
United States	Advocate Health	Downers Grove	Illinois
United States	Atlantic Medical Imaging	Galloway	New Jersey
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	US Departmetn of Veterans Affairs, Oklahoma VA Medical Center	Oklahoma City	Oklahoma
United States	Florida Hospital Heartland Medical Center	Sebring	Florida
United States	Endovascular Technologies, LLC	Shreveport	Louisiana
United States	Promedica Toledo Hospital	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Midwest Cardiovascular Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (8)

Beschorner U, Krankenberg H, Scheinert D, Sievert H, Tübler 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. — View Citation

Bosiers M, Deloose K, Callaert J, Verbist J, Hendriks J, Lauwers P, Schroë 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. — View 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. — View Citation

Krankenberg H, Tübler T, Ingwersen M, Schlüter 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Target Lesion Revascularization (TLR)	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)	6 months
Primary	Major Adverse Events (MAE)	unplanned major amputation, all cause mortality, and Bailout Stenting consider Target Lesion Revascularization (TLR).	30 days
Secondary	Device Outcome	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.	Intraprocedural
Secondary	Procedural Success	Defined as =30% residual diameter stenosis following JS + PTA without provisional or bailout procedures	Intraprocedural
Secondary	Target Lesion Revascularization (TLR) With no Bailout Stent Included	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)	6 months
Secondary	Target Lesion Revascularization (TLR)	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)	1 year
Secondary	Clinical Patency	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 months
Secondary	Clinical Patency	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)	1 year
Secondary	Change in Walking Impairment Questionnaire Score	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)	Baseline and 6 months
Secondary	Number of Participants With Rutherford Clinical Category Improvement	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.	6 months
Secondary	Change in Ankle-Brachial Index	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).	6 months
Secondary	Change in Walking Impairment Questionnaire at 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.	1 Year
Secondary	Rutherford Clinical Category	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.	1 Year
Secondary	Ankle Brachial Index	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)	1 Year
Secondary	Clinically Driven Target Lesion Revascularization	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.	6 months
Secondary	Clinically Driven Target Lesion Revascularization	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.	12 months