CompletedNCT02730234JET-ISRUpdated Aug 11, 2021Results posted

JetStream Atherectomy for the Treatment of In-stent Restenosis

An interventional study of JetStream XC with balloon angioplasty in Femoropopliteal In-stent Restenosis, sponsored by Midwest Cardiovascular Research Foundation. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-11.

Sponsored by Midwest Cardiovascular Research Foundation · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Femoropopliteal In-stent Restenosis

In context

Lead sponsor

Midwest Cardiovascular Research Foundation is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients with symptomatic peripheral arterial disease (Rutherford Becker Class II to IV)
Previously treated with stenting in the femoropopliteal segment
No limit on how many times the target in-stent restenotic lesion has been previously treated.
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
There is no limit on the length of the target lesion as long as only one target lesion is treated and enrolled

Exclusion criteria

Exclusion Criteria:

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

Subject is 18 years of age or older.
Subject presents with clinical evidence of peripheral arterial disease with ISR in the femoropopliteal segment (includes common femoral, superficial femoral and popliteal)
Subject presents with a Rutherford Classification of 2-4 and has symptoms of rest limb pain or claudication.
Target lesion(s) must be viewed angiographically and have ≥50% stenosis.
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.
The main target vessel reference diameter must be > or = 5 mm and ≤ 7 mm
One patent distal run-off vessel with \<70% disease and with brisk flow is required.
Intraluminal crossing of the lesion. If this is not certain, IVUS may be used to verify this per operator's discretion
Patient has signed approved informed consent.
Patient is willing to comply with the follow-up evaluations at specified times.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 60 participants (actual)

Study arms

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

Interventions

DeviceJetStream 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.
Also known as: JetStream Navitus

What researchers measure

Primary outcomes

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)
Time frame: 6 months
Major Adverse Events (MAE)
unplanned major amputation, all cause mortality, and Bailout Stenting consider Target Lesion Revascularization (TLR).
Time frame: 30 days

Secondary outcomes

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.
Time frame: Intraprocedural
Procedural Success
Defined as ≤30% residual diameter stenosis following JS + PTA without provisional or bailout procedures
Time frame: Intraprocedural
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)
Time frame: 6 months
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)
Time frame: 1 year
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)
Time frame: 6 months
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)
Time frame: 1 year
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)
Time frame: Baseline and 6 months
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.
Time frame: 6 months
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).
Time frame: 6 months
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.
Time frame: 1 Year
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.
Time frame: 1 Year
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)
Time frame: 1 Year
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.
Time frame: 6 months
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.
Time frame: 12 months

Results

Posted Jan 29, 2021

Limitations and caveats

The built in aspiration system may reduce potential debris, although it does not eliminate this problem completely. Lack of safety data in class III and IV stent fractures and the safety of the device in tortuous vessels (\>45 degrees) has not been demonstrated given wire bias in these vessels.

Participant flow

Participant flow — Overall Study
Milestone	JetStream XC With Balloon Angioplasty
Started	60
Completed	52
Not completed	8

Outcome measures

PrimaryPercentage 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)

Time frame:: 6 months
Reported as:: Count of participants · Participants

Percentage of Participants With Target Lesion Revascularization (TLR)
Participants	JetStream XC With Balloon Angioplasty
Percentage of Participants With Target Lesion Revascularization (TLR)	12

PrimaryMajor Adverse Events (MAE)

unplanned major amputation, all cause mortality, and Bailout Stenting consider Target Lesion Revascularization (TLR).

Time frame:: 30 days
Reported as:: Count of participants · Participants

Major Adverse Events (MAE)
Participants	JetStream XC With Balloon Angioplasty
Major Adverse Events (MAE)	6

SecondaryDevice 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.

Time frame:: Intraprocedural
Reported as:: Count of participants · Participants

Device Outcome
Participants	JetStream XC With Balloon Angioplasty
Device Outcome	25

SecondaryProcedural Success

Defined as ≤30% residual diameter stenosis following JS + PTA without provisional or bailout procedures

Time frame:: Intraprocedural
Reported as:: Count of participants · Participants

Procedural Success
Participants	JetStream XC With Balloon Angioplasty
Procedural Success	35

SecondaryTarget 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)

Time frame:: 6 months
Reported as:: Count of participants · Participants

Target Lesion Revascularization (TLR) With no Bailout Stent Included
Participants	JetStream XC With Balloon Angioplasty
Target Lesion Revascularization (TLR) With no Bailout Stent Included	6

SecondaryTarget 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)

Time frame:: 1 year
Reported as:: Count of participants · Participants

Target Lesion Revascularization (TLR)
Participants	JetStream XC With Balloon Angioplasty
Target Lesion Revascularization (TLR)	18

SecondaryClinical 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)

Time frame:: 6 months
Reported as:: Count of participants · Participants

Clinical Patency
Participants	JetStream XC With Balloon Angioplasty
Clinical Patency	31

SecondaryClinical Patency

Time frame:: 1 year
Reported as:: Count of participants · Participants

Clinical Patency
Participants	JetStream XC With Balloon Angioplasty
Clinical Patency	15

SecondaryChange 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)

Time frame:: Baseline and 6 months
Reported as:: Mean · score on a scale

Change in Walking Impairment Questionnaire Score
score on a scale	JetStream XC With Balloon Angioplasty
Change in Walking Impairment Questionnaire Score	21.8 (12.9 to 34.5)

SecondaryNumber 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.

Time frame:: 6 months
Reported as:: Number · participants

Number of Participants With Rutherford Clinical Category Improvement
participants	JetStream XC With Balloon Angioplasty
Number of Participants With Rutherford Clinical Category Improvement	38

SecondaryChange 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).

Time frame:: 6 months
Reported as:: Mean · units on a scale

Change in Ankle-Brachial Index
units on a scale	JetStream XC With Balloon Angioplasty
Change in Ankle-Brachial Index	0.2 ± 0.3

SecondaryChange 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.

Time frame:: 1 Year
Reported as:: Mean · score on a scale

Change in Walking Impairment Questionnaire at 1 Year
score on a scale	JetStream XC With Balloon Angioplasty
Change in Walking Impairment Questionnaire at 1 Year	38.7 ± 10.0

SecondaryRutherford 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.

Time frame:: 1 Year
Reported as:: Count of participants · Participants

Rutherford Clinical Category
Participants	JetStream XC With Balloon Angioplasty
Rutherford Clinical Category	35

SecondaryAnkle 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)

Time frame:: 1 Year
Reported as:: Mean · units on a scale

Ankle Brachial Index
units on a scale	JetStream XC With Balloon Angioplasty
Ankle Brachial Index	0.2 (0.2 to 0.3)

SecondaryClinically 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.

Time frame:: 6 months
Reported as:: Count of participants · Participants

Clinically Driven Target Lesion Revascularization
Participants	JetStream XC With Balloon Angioplasty
Clinically Driven Target Lesion Revascularization	8

SecondaryClinically 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.

Time frame:: 12 months
Reported as:: Count of participants · Participants

Clinically Driven Target Lesion Revascularization
Participants	JetStream XC With Balloon Angioplasty
Clinically Driven Target Lesion Revascularization	11

Adverse events

Collected over Major Adverse Events were collected for up to 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
JetStream XC With Balloon Angioplasty	8/60 (13.3%)	21/60 (35%)	15/60 (25%)

Most frequent serious events

Most frequent serious events
Event	JetStream XC With Balloon Angioplasty
Target Lesion Revascularization with Bailout StentingVascular disorders	21/60
Target Lesion Revascularization without Bailout StentingVascular disorders	11/60
Distal EmbolizationVascular disorders	8/60
Major BleedingBlood and lymphatic system disorders	1/60
Nonfatal myocardial InfarctionCardiac disorders	1/60
Unplanned Major amputationVascular disorders	0/60
New Stent Fracture or DisruptionVascular disorders	0/60
Device Induced Vascular InjuryVascular disorders	0/60

Most frequent other events

Most frequent other events
Event	JetStream XC With Balloon Angioplasty
worsening claudication in non affected limbVascular disorders	11/60
AnginaCardiac disorders	4/60

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	JetStream XC With Balloon Angioplasty
<=18 years	0
Between 18 and 65 years	22
>=65 years	38

Age, Continuous
Age, Continuous(years)	JetStream XC With Balloon Angioplasty
Mean	70.2 (49 to 96)

Sex: Female, Male
Sex: Female, Male(Participants)	JetStream XC With Balloon Angioplasty
Female	20
Male	40

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	JetStream XC With Balloon Angioplasty
white	51
Hispanic	1
African American	8

Region of Enrollment
Region of Enrollment(participants)	JetStream XC With Balloon Angioplasty
United States	60

Body Mass Index
Body Mass Index(kg/m^2)	JetStream XC With Balloon Angioplasty
Mean	28.4 ± 6.0

Study locations

13 sites

Eastern Colorado Healthcare System
Denver, Colorado 80220, United States
Florida Hospital Heartland Medical Center
Sebring, Florida 33872, United States
Advocate Health
Downers Grove, Illinois 60515, United States
Midwest Cardiovascular Research Foundation/Trinity Medical Center
Bettendorf, Iowa 52722, United States
Midwest Cardiovascular Research Foundation/Genesis Medical Center
Davenport, Iowa 52722, United States
Endovascular Technologies, LLC
Shreveport, Louisiana 71103, United States
Atlantic Medical Imaging
Galloway, New Jersey 08205, United States
New Mexico Heart Institute
Albuquerque, New Mexico 87101, United States
Promedica Toledo Hospital
Toledo, Ohio 43606, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma 73104, United States
US Departmetn of Veterans Affairs, Oklahoma VA Medical Center
Oklahoma City, Oklahoma 73104, United States
Medical University of South Carolina
Charleston, South Carolina 29425, United States
VA North Texas Health Care System: Dallas VA Medical Center
Dallas, Texas 75216, United States

References and documents

Publications

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. PubMed 26109627 ↗
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. PubMed 26446728 ↗
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. PubMed 23485840 ↗
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. PubMed 26596178 ↗
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. PubMed 26921281 ↗
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. PubMed 25775672 ↗
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. PubMed 25499305 ↗
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. PubMed 26060377 ↗
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. PubMed 32885736 ↗

Study documents

Protocol and statistical analysis plan · Feb 29, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Data will be shared in aggregate in a manuscript. No plan to share individual patient data

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02730234
Lead sponsor: Midwest Cardiovascular Research Foundation
Responsible party: Sponsor
First posted: Apr 6, 2016
Start date: Apr 2016
Primary completion: Feb 4, 2020
Completion: Sep 24, 2020
Results posted: Jan 29, 2021
Last update: Aug 11, 2021

Study contacts

Nicolas W Shammass, MD, MS

principal investigator · Midwest Cardiovascular Research Foundation

Subhash Banerjee, MD

principal investigator · VAMC, Dallas, Texas

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Midwest Cardiovascular Research Foundation

Start the discussion