Outcomes in Femoropopliteal Disease Stratified by Translesional Pressure Gradient

NCT02387658 | Completed

• 1 other identifier: Dallas VA IRB Protocol #14-076
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To perform an observational analysis to determine if mean translesional gradient measurements (TLG) are associated with differences in clinical outcomes in patients with femoropopliteal arterial disease and claudication.
2. 2.Hypothesis: Patients stratified by a residual translesional gradient \</= 11 mmHg after peripheral revascularization or angiography alone will have better clinical outcomes than patients with TLG \> 11 mmHg as assessed by six minute walk (6MW), walking impairment questionnaire scores (WIQ), ankle brachial index and need for repeat procedure at 6 months.

Conditions

Peripheral Arterial Disease; Claudication

Keywords

peripheral arterial disease; claudication; translesional pressure gradient; pressure wire; six minute walk; superficial femoral artery; pressure gradient; endovascular

Outcome Measures

Primary Outcomes (1)

• Change in six minute walk distance in meters at 6 months

  Compare change in six minute walk distance at 2 weeks post angiography +/- revascularization to distance walked at 6 months +/- 15 days between patients stratified by a residual mean translesional gradient \> 11 mmHg or \</= 11 mmHg. The six minute walk test involves walking in a straight 100m hallway back and forth for as far as possible during a six minute time span.

  6 months +/- 15 days after enrollment

Secondary Outcomes (5)

• Change Walking Impairment Questionairre (WIQ)Score at 6 months

  6 months +/- 15 days after enrollment

• Change in Ankle Brachial Index (ABI) at 6 months

  6months +/- 15 days after enrollment

• Change in six minute walk distance from baseline to within 2 weeks post revascularization

  baseline pre revascularization to two weeks post measurement

• Change in WIQ score from baseline to within 2 weeks post revascularization

  baseline pre revascularization to two weeks post measurement

• Need for repeat revascularization or amputation as assessed by rates of need in repeat revascularization or amputation

  six months

Other Outcomes (2)

• Secondary analysis evaluating correlation between change in 6 minute walk distance at 6 month and residual translesional gradients.

  6 months

• Secondary analysis evaluating correlation in change in WIQ score at 6 month and residual translesional gradients.

  6 months

Study Arms (2)

final TLG </=11 mmHg

includes all patients who have a final mean translesional gradient measurement (TLG) \< 11 mmHg regardless if revascularization is done or not.

Procedure: translesional gradient measurement

final TLG > 11 mmHg

includes all patients who have a final mean translesional gradient measurement (TLG) \> 11 mmHg regardless if revascularization is done or not.

Procedure: translesional gradient measurement

Interventions

translesional gradient measurement PROCEDURE

Patients will be stratified into two groups based on the final mean translesional pressure gradient obtained in the femoropopliteal arterial bed after revascularization or just after angiography if no revascularization is done.

final TLG </=11 mmHg; final TLG > 11 mmHg

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

Patients with claudication symptoms and femoropopliteal disease referred for peripheral angiography and possible revascularization.

You may qualify if:

• Signed informed consent
• At least 18 years old
• Unilateral lower limb claudication Rutherford class 2-4
• Subjects must be able to complete screening six minute walk, walking impairment questionnaire, and baseline ankle brachial index
• Estimated survival ≥1 year in the judgment of the primary operator
• Documented symptomatic femoropopliteal (FP) atherosclerotic disease with at least moderate angiographic stenosis in the symptomatic lower extremity
• Subjects with multilevel disease can be screened and enrolled after treatment of other non FP PAD

You may not qualify if:

• Life expectancy less than 12 months or other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial
• Severe Bilateral claudication
• Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated
• Known hypersensitivity to adenosine or moderate to severe asthma
• Pregnancy
• Serum Creatinine \>2.5
• Vascular graft, aneurysm or postsurgical stenosis of the target vessel
• Documented untreated severe iliac or below-the knee stenosis with \< 2 vessel run-off in leg with femoropopliteal stenosis or untreated bilateral symptomatic peripheral arterial disease

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead

Study Sites (1)

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

Related Publications (8)

• Klein AJ, Pinto DS, Gray BH, Jaff MR, White CJ, Drachman DE; Peripheral Vascular Disease Committee for the Society for Cardiovascular Angiography and Interventions. SCAI expert consensus statement for femoral-popliteal arterial intervention appropriate use. Catheter Cardiovasc Interv. 2014 Oct 1;84(4):529-38. doi: 10.1002/ccd.25504. Epub 2014 Jun 12.

  PMID: 24753020 BACKGROUND

• Walker C. What is the role of translesional pressure gradient measurement in peripheral intervention? J Invasive Cardiol. 2011 Sep;23(9):357. No abstract available.

  PMID: 21891804 BACKGROUND

• Archie JP Jr. Analysis and comparison of pressure gradients and ratios for predicting iliac stenosis. Ann Vasc Surg. 1994 May;8(3):271-80. doi: 10.1007/BF02018175.

  PMID: 8043361 BACKGROUND

• Banerjee S, Badhey N, Lichtenwalter C, Varghese C, Brilakis ES. Relationship of walking impairment and ankle-brachial index assessments with peripheral arterial translesional pressure gradients. J Invasive Cardiol. 2011 Sep;23(9):352-6.

  PMID: 21891803 BACKGROUND

• Garcia LA, Carrozza JP Jr. Physiologic evaluation of translesion pressure gradients in peripheral arteries: comparison of pressure wire and catheter-derived measurements. J Interv Cardiol. 2007 Feb;20(1):63-5. doi: 10.1111/j.1540-8183.2007.00213.x.

  PMID: 17300406 BACKGROUND

• De Bruyne B, Manoharan G, Pijls NH, Verhamme K, Madaric J, Bartunek J, Vanderheyden M, Heyndrickx GR. Assessment of renal artery stenosis severity by pressure gradient measurements. J Am Coll Cardiol. 2006 Nov 7;48(9):1851-5. doi: 10.1016/j.jacc.2006.05.074. Epub 2006 Oct 17.

  PMID: 17084261 BACKGROUND

• Belch JJ, Topol EJ, Agnelli G, Bertrand M, Califf RM, Clement DL, Creager MA, Easton JD, Gavin JR 3rd, Greenland P, Hankey G, Hanrath P, Hirsch AT, Meyer J, Smith SC, Sullivan F, Weber MA; Prevention of Atherothrombotic Disease Network. Critical issues in peripheral arterial disease detection and management: a call to action. Arch Intern Med. 2003 Apr 28;163(8):884-92. doi: 10.1001/archinte.163.8.884. No abstract available.

  PMID: 12719196 BACKGROUND

• Tetteroo E, van Engelen AD, Spithoven JH, Tielbeek AV, van der Graaf Y, Mali WP. Stent placement after iliac angioplasty: comparison of hemodynamic and angiographic criteria. Dutch Iliac Stent Trial Study Group. Radiology. 1996 Oct;201(1):155-9. doi: 10.1148/radiology.201.1.8816537.

  PMID: 8816537 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Cardiology North Texas VA Medical Center

Study Record Dates

• First Submitted: March 8, 2015
• First Posted: March 13, 2015
• Study Start: February 6, 2015
• Primary Completion: July 13, 2016
• Study Completion: July 13, 2016
• Last Updated: September 12, 2018

Record last verified: 2018-09

Locations

US (1)