ACHIEVE GRX Registry

NCT04513613 | Withdrawn FDA Device

• 1 other identifier: 104-09200
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate real-world performance of the CorPath GRX System in peripheral vascular interventions.

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Renal Artery Disease; Carotid Artery Diseases

Outcome Measures

Primary Outcomes (3)

• Technical Success

  Successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy.

  Procedure

• Clinical Success

  \<30% residual stenosis in all CorPath System treated lesions at the completion of the interventional procedure in the absence of device-related serious adverse event (SAE).

  Within 24 hours of the procedure or hospital discharge, whichever occurs first.

• Safety

  A composite of intra- and peri-procedural events, including target vessel rupture, clinically significant perforation or dissection, and distal embolization.

  Within 24 hours of the procedure or hospital discharge, whichever occurs first.

Secondary Outcomes (8)

• PVI Procedure Time

  Procedure

• Manual Time

  Procedure

• Robotic Time

  Procedure

• Fluoroscopy Time

  Procedure

• Operator Radiation Exposure

  Procedure

Study Arms (1)

Subjects with a clinical indication for PVI

Subjects with a clinical indication for Peripheral Vascular Intervention (PVI).

Device: Procedure/Surgery: Robotic-PVI

Interventions

Procedure/Surgery: Robotic-PVI DEVICE

Robotic-assisted (CorPath GRX System) percutaneous vascular interventions.

Subjects with a clinical indication for PVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with a clinical indication for Peripheral Vascular Intervention (PVI).

You may qualify if:

• Age ≥ 18 years.
• Subject has a clinical indication for Peripheral Vascular Intervention (PVI).
• Subject is deemed appropriate for robotic-assisted PVI.
• The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
• Individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure.

You may not qualify if:

• Failure/inability/unwillingness to provide informed consent.
• The investigator determines the subject or the peripheral anatomy is not suitable for ro-botic-assisted PVI.
• Women who are pregnant.

Sponsors & Collaborators

• Corindus Inc.: lead

Related Publications (23)

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• Canfield J, Totary-Jain H. 40 Years of Percutaneous Coronary Intervention: History and Future Directions. J Pers Med. 2018 Oct 1;8(4):33. doi: 10.3390/jpm8040033.

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• Benjamin R, Lui F. Vertebrobasilar Insufficiency. 2025 Dec 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482259/

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• Schoepe R, McQuillan S, Valsan D, Teehan G. Atherosclerotic Renal Artery Stenosis. Adv Exp Med Biol. 2017;956:209-213. doi: 10.1007/5584_2016_89.

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• Writing Committee Members; Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FGR, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RAG, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME; ACC/AHA Task Force Members; Halperin JL, Levine GN, Al-Khatib SM, Birtcher KK, Bozkurt B, Brindis RG, Cigarroa JE, Curtis LH, Fleisher LA, Gentile F, Gidding S, Hlatky MA, Ikonomidis J, Joglar J, Pressler SJ, Wijeysundera DN. 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: Executive Summary. Vasc Med. 2017 Jun;22(3):NP1-NP43. doi: 10.1177/1358863X17701592. No abstract available.

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• White RD, Weir-McCall JR, Sullivan CM, Mustafa SA, Yeap PM, Budak MJ, Sudarshan TA, Zealley IA. The celiac axis revisited: anatomic variants, pathologic features, and implications for modern endovascular management. Radiographics. 2015 May-Jun;35(3):879-98. doi: 10.1148/rg.2015140243. Epub 2015 Apr 17.

  PMID: 25884099 BACKGROUND

• Beckman JA, Creager MA. Chapter 18 Peripheral Artery Disease Clinical Evaluation. In: Creager MA, Beckman JA, Loscalzo J, eds. Vascular Medicine: A Companion to Braunwald's Heart Disease. Philadelphia, PA: Elsevier Saunders; 2013

  BACKGROUND

• Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.

  PMID: 23915883 BACKGROUND

• Allison MA, Ho E, Denenberg JO, Langer RD, Newman AB, Fabsitz RR, Criqui MH. Ethnic-specific prevalence of peripheral arterial disease in the United States. Am J Prev Med. 2007 Apr;32(4):328-33. doi: 10.1016/j.amepre.2006.12.010.

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• Klein LW, Miller DL, Balter S, Laskey W, Haines D, Norbash A, Mauro MA, Goldstein JA; Joint Inter-Society Task Force on Occupational Hazards in the Interventional Laboratory. Occupational health hazards in the interventional laboratory: time for a safer environment. Catheter Cardiovasc Interv. 2009 Feb 15;73(3):432-8. doi: 10.1002/ccd.21801.

  PMID: 19214981 BACKGROUND

• Kim KP, Miller DL, Balter S, Kleinerman RA, Linet MS, Kwon D, Simon SL. Occupational radiation doses to operators performing cardiac catheterization procedures. Health Phys. 2008 Mar;94(3):211-27. doi: 10.1097/01.HP.0000290614.76386.35.

  PMID: 18301095 BACKGROUND

• Vano E, Gonzalez L, Beneytez F, Moreno F. Lens injuries induced by occupational exposure in non-optimized interventional radiology laboratories. Br J Radiol. 1998 Jul;71(847):728-33. doi: 10.1259/bjr.71.847.9771383.

  PMID: 9771383 BACKGROUND

• Goldsweig AM, Abbott JD, Aronow HD. Physician and Patient Radiation Exposure During Endovascular Procedures. Curr Treat Options Cardiovasc Med. 2017 Feb;19(2):10. doi: 10.1007/s11936-017-0507-9.

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• El-Sayed T, Patel AS, Cho JS, Kelly JA, Ludwinski FE, Saha P, Lyons OT, Smith A, Modarai B; Guy's and St Thomas' Cardiovascular Research Collaborative. Radiation-Induced DNA Damage in Operators Performing Endovascular Aortic Repair. Circulation. 2017 Dec 19;136(25):2406-2416. doi: 10.1161/CIRCULATIONAHA.117.029550. Epub 2017 Oct 20.

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  PMID: 27639904 BACKGROUND

• Vano E, Gonzalez L, Fernandez JM, Haskal ZJ. Eye lens exposure to radiation in interventional suites: caution is warranted. Radiology. 2008 Sep;248(3):945-53. doi: 10.1148/radiol.2482071800. Epub 2008 Jul 15.

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• Weisz G, Metzger DC, Caputo RP, Delgado JA, Marshall JJ, Vetrovec GW, Reisman M, Waksman R, Granada JF, Novack V, Moses JW, Carrozza JP. Safety and feasibility of robotic percutaneous coronary intervention: PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) Study. J Am Coll Cardiol. 2013 Apr 16;61(15):1596-600. doi: 10.1016/j.jacc.2012.12.045.

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• Smitson CC, Ang L, Pourdjabbar A, Reeves R, Patel M, Mahmud E. Safety and Feasibility of a Novel, Second-Generation Robotic-Assisted System for Percutaneous Coronary Intervention: First-in-Human Report. J Invasive Cardiol. 2018 Apr;30(4):152-156. Epub 2018 Jan 15.

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MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jon George, MD

  Einstein Medical Center

  PRINCIPAL INVESTIGATOR

• John Phillips, MD

  Riverside Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 14, 2020
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: April 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share