ACHIEVE GRX Registry

Peripheral Arterial Disease Clinical Trial

Official title:

A Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Peripheral Vascular Interventions

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04513613
• Other study ID #: 104-09200
• Status: Withdrawn
• Start date: January 2022
• Est. completion date: January 2023

Study information

• Verified date: March 2021
• Source: Corindus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

This is a prospective, single-arm, open-label, multi-center registry of the CorPath GRX System to evaluate its real-world performance during peripheral vascular interventions.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years.

2. Subject has a clinical indication for Peripheral Vascular Intervention (PVI).

3. Subject is deemed appropriate for robotic-assisted PVI.

4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

5. Individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure.

Exclusion Criteria:

1. Failure/inability/unwillingness to provide informed consent.

2. The investigator determines the subject or the peripheral anatomy is not suitable for ro-botic-assisted PVI.

3. Women who are pregnant.

Related Conditions & MeSH terms

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

Intervention

Device:
• Procedure/Surgery: Robotic-PVI
Robotic-assisted (CorPath GRX System) percutaneous vascular interventions.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Corindus Inc.

References & Publications (23)

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. Erratum in: Am J Prev Med. 2014 Jul;47(1):103. — View Citation

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

Canfield J, Totary-Jain H. 40 Years of Percutaneous Coronary Intervention: History and Future Directions. J Pers Med. 2018 Oct 1;8(4). pii: E33. doi: 10.3390/jpm8040033. Review. — View Citation

Dalal PK, Prasad A. Contemporary Outcomes of Endovascular Intervention for Critical Limb Ischemia. Interv Cardiol Clin. 2017 Apr;6(2):251-259. doi: 10.1016/j.iccl.2016.12.008. Epub 2017 Jan 27. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Goldsweig AM, Kennedy KF, Kolte D, Abbott JD, Gordon PC, Sharaf BL, Sellke FW, Ehsan A, Sodha NR, Rutar F, Aronow HD. Predictors of patient radiation exposure during transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2018 Oct 1;92(4):768-774. doi: 10.1002/ccd.27452. Epub 2017 Dec 27. — View Citation

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. Review. — View Citation

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. — View Citation

Mahmud E, Dominguez A, Bahadorani J. First-in-human robotic percutaneous coronary intervention for unprotected left main stenosis. Catheter Cardiovasc Interv. 2016 Oct;88(4):565-570. doi: 10.1002/ccd.26550. Epub 2016 May 18. — View Citation

Mahmud E, Schmid F, Kalmar P, Deutschmann H, Hafner F, Rief P, Brodmann M. Feasibility and Safety of Robotic Peripheral Vascular Interventions: Results of the RAPID Trial. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2058-2064. doi: 10.1016/j.jcin.2016.07.002. Epub 2016 Sep 14. — View Citation

Pirau L, Lui F. Vertebrobasilar Insufficiency. 2020 Jul 21. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482259/ — View Citation

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. Review. — View Citation

Smilowitz NR, Moses JW, Sosa FA, Lerman B, Qureshi Y, Dalton KE, Privitera LT, Canone-Weber D, Singh V, Leon MB, Weisz G. Robotic-Enhanced PCI Compared to the Traditional Manual Approach. J Invasive Cardiol. 2014 Jul;26(7):318-21. — View Citation

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. — View Citation

Uccioli L, Meloni M, Izzo V, Giurato L, Merolla S, Gandini R. Critical limb ischemia: current challenges and future prospects. Vasc Health Risk Manag. 2018 Apr 26;14:63-74. doi: 10.2147/VHRM.S125065. eCollection 2018. Review. — View Citation

van Dijk LJ, van Noord D, de Vries AC, Kolkman JJ, Geelkerken RH, Verhagen HJ, Moelker A, Bruno MJ. Clinical management of chronic mesenteric ischemia. United European Gastroenterol J. 2019 Mar;7(2):179-188. doi: 10.1177/2050640618817698. Epub 2018 Dec 4. Review. — View Citation

Vañó E, González 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. Review. — View Citation

Vano E, Gonzalez L, Fernández 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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	PVI Procedure Time	Defined as the time measured from the insertion of the guiding sheath until the removal of the guiding sheath.	Procedure
Secondary	Manual Time	Defined as the total amount of time the procedure is completed using a manual technique.	Procedure
Secondary	Robotic Time	Defined as the total amount of time the procedure is completed robotically from the robotic cock-pit.	Procedure
Secondary	Fluoroscopy Time	Total fluoroscopy utilized during the procedure as recorded by an Imaging System.	Procedure
Secondary	Operator Radiation Exposure	Cumulative dose the operator receives as recorded from an electronic pocket dosimeter during the procedure.	Procedure
Secondary	Staff Radiation Exposure	Cumulative dose the staff receives as recorded from an electronic pocket dosimeter during the procedure.	Procedure
Secondary	Patient Radiation Exposure	DAP (dose-area-product) and AK (air kerma) as recorded during the procedure.	Procedure
Secondary	Contrast Fluid Volume	Total volume of contrast (mL) used during the procedure.	Procedure