VQI DELTA Paclitaxel Device Safety Analysis

NCT04110288 | Completed FDA Drug

• 2 other identifiers: 20193123U01FD004963
• Study Type: observational
• Target: 219,483
• Locations: 1 country
• Sites: 1

Brief Summary

The VQI-DELTA Paclitaxel Device Safety Analysis seeks to assess the comparative safety of paclitaxel coated balloons and stents in the treatment of peripheral artery disease (PAD) through analysis of the VQI Peripheral Vascular Intervention (PVI) registry module using the DELTA system.

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Survival from Death

  Freedom from death of any cause

  2 years post intervention

Secondary Outcomes (2)

• Intervention Success

  2 year post intervention

• Successful Ambulation

  1 year post intervention

Other Outcomes (1)

• Falsification - Freedom from Resuming Smoking

  2 year post intervention

Study Arms (4)

Uncoated Balloon Treatment

Patients treated for PAD with balloon angioplasty, without use of stent.

Device: Non-drug coated Device Treatment

Bare Metal Stent Treatment

Patients treated for PAD with implantation of bare metal stent.

Device: Non-drug coated Device Treatment

Paclitaxel Coated Balloon

Patients treated for PAD with drug coated balloon angioplasty, without use of stent.

Drug: Paclitaxel

Paclitaxel Eluting Stent

Patients treated for PAD with implantation of Paclitaxel DES.

Drug: Paclitaxel

Interventions

Paclitaxel DRUG

Paclitaxel to treat peripheral arterial disease

Also known as: Taxol

Paclitaxel Coated Balloon; Paclitaxel Eluting Stent

Non-drug coated Device Treatment DEVICE

Bare Metal Stent Treatment; Uncoated Balloon Treatment

Eligibility Criteria

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

Study Population

All patients, age 18 or older, who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic PAD between 1/1/17 through 4/1/2020 will be candidates for inclusion in the analyses.

You may qualify if:

• All patients who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic Peripheral Artery Disease.

You may not qualify if:

• In an effort to focus this safety evaluation on those patients being treated in accordance with accepted 'best practice' endovascular intervention strategies and 'on-label' use of devices, patients will be excluded from either exposure cases or controls if they received a balloon expandable stent or a balloon expandable stent graft in the treatment of femoral or popliteal disease. Balloon expandable stents were excluded because these stents have historically shown inferior patency and current best practice favors placement of self-expanding nitinol stents which were engineered for the femoral popliteal segment and tested in multiple trials for this indication 12-14.
• Additionally, patients will be excluded (as either potential cases or controls) if their index procedure was performed for acute limb ischemia due to the different etiologies (embolism, in-situ thrombosis) as compared with chronic conditions as they have different treatment paradigms and higher major amputation and mortality rates.
• In addition, patients with prior angioplasty or stenting of the superficial femoral artery (SFA)-popliteal segment will be excluded in order to avoid the possibility of improperly assigning paclitaxel exposure to the control group.

Sponsors & Collaborators

• Lahey Clinic: lead
• Society for Vascular Surgery Patient Safety Organization: collaborator

Study Sites (1)

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Related Publications (18)

• 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

• Resnic FS, Majithia A, Marinac-Dabic D, Robbins S, Ssemaganda H, Hewitt K, Ponirakis A, Loyo-Berrios N, Moussa I, Drozda J, Normand SL, Matheny ME. Registry-Based Prospective, Active Surveillance of Medical-Device Safety. N Engl J Med. 2017 Feb 9;376(6):526-535. doi: 10.1056/NEJMoa1516333. Epub 2017 Jan 25.

  PMID: 28121489 BACKGROUND

• Kumar A, Matheny ME, Ho KK, Yeh RW, Piemonte TC, Waldman H, Shah PB, Cope R, Normand SL, Donnelly S, Robbins S, Resnic FS. The data extraction and longitudinal trend analysis network study of distributed automated postmarket cardiovascular device safety surveillance. Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):38-46. doi: 10.1161/CIRCOUTCOMES.114.001123. Epub 2014 Dec 9.

  PMID: 25491915 BACKGROUND

• Resnic FS, Gross TP, Marinac-Dabic D, Loyo-Berrios N, Donnelly S, Normand SL, Matheny ME. Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices. JAMA. 2010 Nov 10;304(18):2019-27. doi: 10.1001/jama.2010.1633.

  PMID: 21063011 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.

  PMID: 15111854 BACKGROUND

• 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.

  PMID: 24768362 BACKGROUND

• 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. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Mar 21;69(11):1465-1508. doi: 10.1016/j.jacc.2016.11.008. Epub 2016 Nov 13. No abstract available.

  PMID: 27851991 BACKGROUND

• Hsieh FY, Lavori PW, Cohen HJ, Feussner JR. An overview of variance inflation factors for sample-size calculation. Eval Health Prof. 2003 Sep;26(3):239-57. doi: 10.1177/0163278703255230.

  PMID: 12971199 BACKGROUND

• Cepeda MS, Boston R, Farrar JT, Strom BL. Comparison of logistic regression versus propensity score when the number of events is low and there are multiple confounders. Am J Epidemiol. 2003 Aug 1;158(3):280-7. doi: 10.1093/aje/kwg115.

  PMID: 12882951 BACKGROUND

• Vidi VD, Matheny ME, Resnic FS. Post-marketing device safety surveillance. Contemp Clin Trials. 2011 May;32(3):307-8. doi: 10.1016/j.cct.2011.02.002. Epub 2011 Feb 28. No abstract available.

  PMID: 21371573 BACKGROUND

• Austin PC. Optimal caliper widths for propensity-score matching when estimating differences in means and differences in proportions in observational studies. Pharm Stat. 2011 Mar-Apr;10(2):150-61. doi: 10.1002/pst.433.

  PMID: 20925139 BACKGROUND

• Oakes D, Feng C. Combining stratified and unstratified log-rank tests in paired survival data. Stat Med. 2010 Jul 20;29(16):1735-45. doi: 10.1002/sim.3921.

  PMID: 20572124 BACKGROUND

• Bertges DJ, Eldrup-Jorgensen J, Robbins S, Ssemaganda H, Malone M, Marinac-Dabic D, Smale J, Lottes AE, Majithia A, Resnic FS; Society for Vascular Surgery Vascular Quality Initiative. Vascular Quality Initiative Surveillance of Femoropopliteal Artery Paclitaxel Devices. JACC Cardiovasc Interv. 2021 Dec 13;14(23):2598-2609. doi: 10.1016/j.jcin.2021.08.058.

  PMID: 34887051 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Frederic S Resnic, MD MSc

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

• Daniel Bertges, MD

  Society for Vascuar Surgery Patient Safety Organization

  STUDY CHAIR

• Jens Eldrup-Jorgensen, MD

  Society for Vascuar Surgery Patient Safety Organization

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair - Division of Cardiovascular Medicine

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 1, 2019
• Study Start: January 1, 2017
• Primary Completion: August 30, 2019
• Study Completion: April 1, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)