AzTrials
AzTrials

Peripheral Arterial DiseaseNCT04513613

ACHIEVE GRX Registry

An observational study of Peripheral Arterial Disease and Peripheral Vascular Diseases, run by Siemens Healthineers Endovascular Robotics, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Procedure/Surgery: Robotic-PVI
Type of treatment
Medical device
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2022to Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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

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

Read the detailed 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.

Being tested
Procedure/Surgery: Robotic-PVI
Medical subject headings
Peripheral Arterial Disease, Peripheral Vascular Diseases, Carotid Artery Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Procedure/Surgery: Robotic-PVIDevice

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

Study groups in NCT04513613
Study groupRoleWhat they receive
Subjects with a clinical indication for PVISubjects with a clinical indication for Peripheral Vascular Intervention (PVI).
Receives: Device: Procedure/Surgery: Robotic-PVI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Procedure

  2. 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).

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

  3. Safety

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

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

Secondary outcomes (8)

  1. PVI Procedure Time

    Defined as the time measured from the insertion of the guiding sheath until the removal of the guiding sheath.

    Measured: Procedure

  2. Manual Time

    Defined as the total amount of time the procedure is completed using a manual technique.

    Measured: Procedure

  3. Robotic Time

    Defined as the total amount of time the procedure is completed robotically from the robotic cock-pit.

    Measured: Procedure

  4. Fluoroscopy Time

    Total fluoroscopy utilized during the procedure as recorded by an Imaging System.

    Measured: Procedure

  5. Operator Radiation Exposure

    Cumulative dose the operator receives as recorded from an electronic pocket dosimeter during the procedure.

    Measured: Procedure

  6. Staff Radiation Exposure

    Cumulative dose the staff receives as recorded from an electronic pocket dosimeter during the procedure.

    Measured: Procedure

  7. Patient Radiation Exposure

    DAP (dose-area-product) and AK (air kerma) as recorded during the procedure.

    Measured: Procedure

  8. Contrast Fluid Volume

    Total volume of contrast (mL) used during the procedure.

    Measured: Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2020
  2. Study startJan 2022 (estimated)
  3. Primary completionJan 2023 (estimated)
  4. Study completionJan 2023 (estimated)

Why it stopped: Sites have adjusted their participation priorities due to the pandemic. Not enough site interest at this current time to initiate the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04513613
Sponsor's protocol ID
104-09200
Status last verified
Mar 2021
First submitted
12 Aug 2020
Last updated
23 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 31080602

  • 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.

    PubMed 29731636

  • 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.

    PubMed 28257772

  • 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.

    PubMed 30275411

  • Benjamin R, Lui F. Vertebrobasilar Insufficiency. 2025 Dec 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482259/

    PubMed 29489229

  • 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.

    PubMed 27873231

  • 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.

    PubMed 28494710

  • 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.

    PubMed 25884099

  • 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

  • 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.

    PubMed 23915883

  • 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.

    PubMed 17383564

  • 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.

    PubMed 19214981

  • 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.

    PubMed 18301095

  • 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.

    PubMed 9771383

  • 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.

    PubMed 28275940

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease and Peripheral Vascular Diseases, run by Siemens Healthineers Endovascular Robotics, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical Success (time frame: Procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04513613, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
ACHIEVE GRX Registry (NCT04513613) | AzTrials