VISION and VQI Paclitaxel Safety Analysis

NCT04204564 | Unknown DMC FDA Device

• 1 other identifier: 1
• Study Type: observational
• Target: 20,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives

1. 1.The VQI-VISION Paclitaxel Device Safety Analysis seeks to assess the comparative safety of paclitaxel-coated balloons and stents in the treatment of PAD through analysis of the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) registry module with linkage to claims. By linking VQI patients to Medicare claims retrospectively from 2012 to 2016, we will be able to identify additional paclitaxel devices enabling longitudinal follow-up of mortality out to 5 years for paclitaxel-eluting stents and 3 years for paclitaxel-coated balloons.
2. 2.To analyze factors associated with mortality, specifically comparing paclitaxel patients surviving vs. paclitaxel patients with mortality. The goal is to identify independent factors predictive of mortality in US pivotal trials and model registry data exposures with sufficient factors to track competing risk paradox and show emulation or not of mortality outcomes with both PTX and PTA exposures.
3. 3.To confirm the effectiveness of paclitaxel devices by comparing reintervention for paclitaxel and non-paclitaxel devices. In-hospital mortality from open and percutaneous target vessel revascularization (TVR) will be reported to determine the impact of subsequent revascularizations on survival. Major amputation will be comparted for patients with chronic limb-threatening ischemia.

Conditions

PAD

Keywords

paclitaxel; drug coated balloon; drug eluting stent; perihpheral vascular intervention; registry

Outcome Measures

Primary Outcomes (3)

• overall mortality

  death from any cause

  1 year

• overall mortality

  death from any cause

  3 years

• overall mortality

  death from any cause

  5 years

Secondary Outcomes (2)

• target vessel revascularization (TVR)

  1-3-5 years

• Major amputation

  1-3-5 years

Study Arms (4)

paclitaxel coated balloon angioplasty

Procedures with paclitaxel coated balloon angioplasty of the superficial femoral-popliteal artery

Device: pactlitaxel PAD device

plain balloon angioplasty

Procedures with plain balloon angioplasty of the superficial femoral-popliteal artery

paclitaxel eluting stent

Procedures with paclitaxel eluting stenting of the superficial femoral-popliteal artery

Device: pactlitaxel PAD device

bare metal stenting

Procedures with bare metal self expanding stenting of the superficial femoral-popliteal artery

Interventions

pactlitaxel PAD device DEVICE

Peripheral vascular intervention on femoral-popliteal occlusive disease with paclitaxel and non-paclitaxel devices.

Also known as: Medtronic INPact Admiral, Bard Lutonix, Cook Zilver PTX stent

paclitaxel coated balloon angioplasty; paclitaxel eluting stent

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients, aged 65 or older, who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic PAD between 10/1/2012 and the latest available CMS dataset (12/31/2016) will be included.

You may qualify if:

• Age ≥ 65 years old
• Date of index procedure is within 10/1/2012 to 12/31/2016
• Symptomatic disease ranging from intermittent claudication to chronic limb-threatening ischemia (including ischemic rest pain and/or tissue loss)
• Elective or urgent procedures

You may not qualify if:

• Aneurysmal disease of the superficial femoral or popliteal artery
• Treatment for acute limb ischemia
• Treatment of common femoral artery or profunda femoral artery occlusive disease
• Emergency procedures
• PVI and concomitant femoral endarterectomy, suprainguinal or infrainguinal bypass

Sponsors & Collaborators

• University of Vermont Medical Center: lead
• The Medical Device Epidemiology Network (MDEpiNet): collaborator
• Society for Vascular Surgery Patient Safety Organization: collaborator

Related Publications (15)

• Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2018 Dec 18;7(24):e011245. doi: 10.1161/JAHA.118.011245.

  PMID: 30561254 BACKGROUND

• Columbo JA, Kang R, Hoel AW, Kang J, Leinweber KA, Tauber KS, Hila R, Ramkumar N, Sedrakyan A, Goodney PP. A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review. J Vasc Surg. 2019 Jan;69(1):74-79.e6. doi: 10.1016/j.jvs.2018.03.423. Epub 2018 Jun 15.

  PMID: 29914838 BACKGROUND

• Schillinger M, Minar E. Past, present and future of femoropopliteal stenting. J Endovasc Ther. 2009 Feb;16 Suppl 1:I147-52. doi: 10.1583/1545-1550-16.16.I-147.

  PMID: 19317587 BACKGROUND

• Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, Koppensteiner R, Minar E, Schillinger M. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009 Dec 1;74(7):1090-5. doi: 10.1002/ccd.22128.

  PMID: 19859954 BACKGROUND

• Chowdhury MM, McLain AD, Twine CP. Angioplasty versus bare metal stenting for superficial femoral artery lesions. Cochrane Database Syst Rev. 2014 Jun 24;2014(6):CD006767. doi: 10.1002/14651858.CD006767.pub3.

  PMID: 24959692 BACKGROUND

• Eliason JL, Wainess RM, Proctor MC, Dimick JB, Cowan JA Jr, Upchurch GR Jr, Stanley JC, Henke PK. A national and single institutional experience in the contemporary treatment of acute lower extremity ischemia. Ann Surg. 2003 Sep;238(3):382-9; discussion 389-90. doi: 10.1097/01.sla.0000086663.49670.d1.

  PMID: 14501504 BACKGROUND

• Earnshaw JJ, Whitman B, Foy C. National Audit of Thrombolysis for Acute Leg Ischemia (NATALI): clinical factors associated with early outcome. J Vasc Surg. 2004 May;39(5):1018-25. doi: 10.1016/j.jvs.2004.01.019.

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• Howard DP, Banerjee A, Fairhead JF, Hands L, Silver LE, Rothwell PM; Oxford Vascular Study. Population-Based Study of Incidence, Risk Factors, Outcome, and Prognosis of Ischemic Peripheral Arterial Events: Implications for Prevention. Circulation. 2015 Nov 10;132(19):1805-15. doi: 10.1161/CIRCULATIONAHA.115.016424. Epub 2015 Sep 8.

  PMID: 26350058 BACKGROUND

• Baril DT, Ghosh K, Rosen AB. Trends in the incidence, treatment, and outcomes of acute lower extremity ischemia in the United States Medicare population. J Vasc Surg. 2014 Sep;60(3):669-77.e2. doi: 10.1016/j.jvs.2014.03.244. Epub 2014 Apr 24.

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• Royston P, Parmar MK. Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome. BMC Med Res Methodol. 2013 Dec 7;13:152. doi: 10.1186/1471-2288-13-152.

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  PMID: 29292533 BACKGROUND

Study Officials

• Daniel Bertges, MD

  SVS VQI

  PRINCIPAL INVESTIGATOR

• Philip Goodney, MD

  SVS VQI

  STUDY DIRECTOR

• Art Sedrakyan, PhD

  Weill Medical College of Cornell University

  STUDY DIRECTOR

• Jens Jorgensen

  SVS PSO

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery and Medicine

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 19, 2019
• Study Start: October 1, 2012
• Primary Completion: December 31, 2016
• Study Completion: June 1, 2020
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share