JetStream Atherectomy for the Treatment of In-stent Restenosis
NCT ID: NCT02730234
Last Updated: 2021-08-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2016-04-30
2020-09-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA
NCT03455855
JET-RANGER Trial - JETStream Atherectomy With Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty Followed by Paclitaxel-Coated Balloon
NCT03206762
Atherectomy and Drug Coated Balloon for the Treatment of Arterio-Venous Graft Stenosis
NCT04627051
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)
NCT03847233
STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)
NCT01927068
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Midwest Cardiovascular Research Foundation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicolas W Shammass, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Midwest Cardiovascular Research Foundation
Subhash Banerjee, MD
Role: PRINCIPAL_INVESTIGATOR
VAMC, Dallas, Texas
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Eastern Colorado Healthcare System
Denver, Colorado, United States
Florida Hospital Heartland Medical Center
Sebring, Florida, United States
Advocate Health
Downers Grove, Illinois, United States
Midwest Cardiovascular Research Foundation/Trinity Medical Center
Bettendorf, Iowa, United States
Midwest Cardiovascular Research Foundation/Genesis Medical Center
Davenport, Iowa, United States
Endovascular Technologies, LLC
Shreveport, Louisiana, United States
Atlantic Medical Imaging
Galloway, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
Promedica Toledo Hospital
Toledo, Ohio, 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
Medical University of South Carolina
Charleston, South Carolina, United States
VA North Texas Health Care System: Dallas VA Medical Center
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MCRF-S-002-2015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.