Peripheral Arterial DiseaseNCT02387658
Outcomes in Femoropopliteal Disease Stratified by Translesional Pressure Gradient
An observational study of Peripheral Arterial Disease and Claudication, run by North Texas Veterans Healthcare System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Claudication
- What is being tested?
- translesional gradient measurement
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2015to 13 Jul 2016
- 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: Patients with claudication symptoms and femoropopliteal disease referred for peripheral angiography and possible revascularization.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA North Texas Health Care System
Dallas, Texas, 75216
About this study
- 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.
- 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.
Read the detailed description
The role of measuring translesional pressure gradients(TLG) in peripheral arterial disease lesions below the iliac artery is unclear. In a previous study the investigators demonstrated that a pressure wire can be effectively used to measure gradients in the femoropopliteal (FP) arterial bed showing good correlation between TLGs recorded with exercise ankle brachial index and walking impairment scores. However there is a no evidence that effectively modifying the gradient or having a high residual gradient after revascularization or just with medical therapy correlates with worse clinical outcomes.
This is a prospective, single center, observational clinical study to evaluate whether measurement of mean residual TLG at the time of angiography and/or immediately after endovascular revascularization are associated with clinically important outcomes in patients with claudication symptoms.
Prior to angiography they will be asked to complete an ankle brachial index evaluation, baseline six minute walk test and walking impairment questionnaire. Arterial access should be obtained in the contralateral common femoral artery to the symptomatic limb if feasible. Angiographic images are to be obtained, interpreted and clinical decisions regarding endovascular treatment are to be made per treating physician's discretion prior to obtaining translesional pressure gradients. In patients whose angiogram does not meet exclusion criteria and do not have a chronic total occlusion (CTO) a baseline TLG will be obtained. A 0.014" pressure wire/catheter to measure pressure will be inserted. After baseline calibration in the superficial femoral artery, the wire will be inserted past the narrowest lesion into the popliteal vessel. Intra-arterial adenosine 100-200 mcg will be given for hyperemia and measurements are to be recorded. If an intervention is planned, repeat measurements are to be obtained at the end of the procedure. If no intervention is planned this will be the residual or final TLG recorded. If baseline measurement are unable to obtained due to a CTO then only a post intervention residual TLG will be obtained and included in analysis. The operator will be blinded to the pre and post TLG measurements by turning the display monitor away from the procedure table and towards the recorder situated in the procedure room when measurements are being obtained.
Patients will follow up within two weeks post angiography for routine scheduled follow up and will obtain repeat ABI, WIQ, and six minute walk if they underwent revascularization. Treating physicians and study coordinators collecting these test measurements will be blinded to TLG measurements but not to angiography and treatment. Patients will again be evaluated at 6 months follow up with repeat ABI, WIQ and six minute walk.
- Conditions
- Peripheral Arterial Disease, Claudication
- Being tested
- translesional gradient measurement
- Keywords
- peripheral arterial disease, claudication, translesional pressure gradient, pressure wire, six minute walk, superficial femoral artery, pressure gradient, endovascular
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
translesional gradient measurementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: translesional gradient measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months +/- 15 days after enrollment
Secondary outcomes (5)
Change Walking Impairment Questionairre (WIQ)Score at 6 months
Compare change in WIQ scores from within 2 weeks post angiography +/- revascularization to WIQ score at 6 months +/- 15 days between patients stratified by a residual mean translesional gradient > 11 mmHg or </= 11 mmHg . The walking impairment score used is based on the patient completing short questionnaire about perceived degree of walking impairment at various distances.
Measured: 6 months +/- 15 days after enrollment
Change in Ankle Brachial Index (ABI) at 6 months
Change in ABI between patients stratified by a residual mean translesional gradient > 11 mmHg or </= 11 mmHg from the index within 2 weeks post TLG measurement to index at 6 months after measurement
Measured: 6months +/- 15 days after enrollment
Change in six minute walk distance from baseline to within 2 weeks post revascularization
Change in six minute walk from baseline measurement in those patients that undergo revascularization to six minute walk distance checked within 2 weeks after revascularization.
Measured: baseline pre revascularization to two weeks post measurement
Change in WIQ score from baseline to within 2 weeks post revascularization
Change in WIQ score from baseline measurement in those patients that undergo revascularization to six minute walk distance checked within 2 weeks after revascularization.
Measured: 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
compare rates of need in repeat revascularization or amputation between patients stratified by a residual mean translesional gradient > 11 mmHg or </= 11 mmHg during 6 month period after TLG measurement.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study start6 Feb 2015
- Primary completion13 Jul 2016
- Study completion13 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Subhash Banerjee, North Texas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387658
- Sponsor's protocol ID
- Dallas VA IRB Protocol #14-076
- Status last verified
- Sep 2018
- First submitted
- 8 Mar 2015
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24753020Walker C. What is the role of translesional pressure gradient measurement in peripheral intervention? J Invasive Cardiol. 2011 Sep;23(9):357. No abstract available.
PubMed 21891804Archie 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.
PubMed 8043361Banerjee 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.
PubMed 21891803Garcia 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.
PubMed 17300406De 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.
PubMed 17084261Belch 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.
PubMed 12719196Tetteroo 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.
PubMed 8816537
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes in Femoropopliteal Disease Stratified by Translesional Pressure Gradient
- ClinicalTrials.gov ID
- NCT02387658
- Acronym / sponsor ID
- Dallas VA IRB Protocol #14-076
- Conditions
- Peripheral Arterial Disease, Claudication
- Keywords
- peripheral arterial disease, claudication, translesional pressure gradient, pressure wire, six minute walk, superficial femoral artery, pressure gradient, endovascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- 6 Feb 2015 (actual)
- Primary completion
- 13 Jul 2016 (actual)
- Study completion
- 13 Jul 2016 (actual)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
Detailed description
The role of measuring translesional pressure gradients(TLG) in peripheral arterial disease lesions below the iliac artery is unclear. In a previous study the investigators demonstrated that a pressure wire can be effectively used to measure gradients in the femoropopliteal (FP) arterial bed showing good correlation between TLGs recorded with exercise ankle brachial index and walking impairment scores. However there is a no evidence that effectively modifying the gradient or having a high residual gradient after revascularization or just with medical therapy correlates with worse clinical outcomes.
This is a prospective, single center, observational clinical study to evaluate whether measurement of mean residual TLG at the time of angiography and/or immediately after endovascular revascularization are associated with clinically important outcomes in patients with claudication symptoms.
Prior to angiography they will be asked to complete an ankle brachial index evaluation, baseline six minute walk test and walking impairment questionnaire. Arterial access should be obtained in the contralateral common femoral artery to the symptomatic limb if feasible. Angiographic images are to be obtained, interpreted and clinical decisions regarding endovascular treatment are to be made per treating physician's discretion prior to obtaining translesional pressure gradients. In patients whose angiogram does not meet exclusion criteria and do not have a chronic total occlusion (CTO) a baseline TLG will be obtained. A 0.014" pressure wire/catheter to measure pressure will be inserted. After baseline calibration in the superficial femoral artery, the wire will be inserted past the narrowest lesion into the popliteal vessel. Intra-arterial adenosine 100-200 mcg will be given for hyperemia and measurements are to be recorded. If an intervention is planned, repeat measurements are to be obtained at the end of the procedure. If no intervention is planned this will be the residual or final TLG recorded. If baseline measurement are unable to obtained due to a CTO then only a post intervention residual TLG will be obtained and included in analysis. The operator will be blinded to the pre and post TLG measurements by turning the display monitor away from the procedure table and towards the recorder situated in the procedure room when measurements are being obtained.
Patients will follow up within two weeks post angiography for routine scheduled follow up and will obtain repeat ABI, WIQ, and six minute walk if they underwent revascularization. Treating physicians and study coordinators collecting these test measurements will be blinded to TLG measurements but not to angiography and treatment. Patients will again be evaluated at 6 months follow up with repeat ABI, WIQ and six minute walk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| final TLG </=11 mmHg | – | Procedure: translesional gradient measurementincludes all patients who have a final mean translesional gradient measurement (TLG) < 11 mmHg regardless if revascularization is done or not. |
| final TLG > 11 mmHg | – | Procedure: translesional gradient measurementincludes all patients who have a final mean translesional gradient measurement (TLG) > 11 mmHg regardless if revascularization is done or not. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with claudication symptoms and femoropopliteal disease referred for peripheral angiography and possible revascularization.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| translesional gradient measurementPatients 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. | Procedure or surgery | final TLG </=11 mmHg, final TLG > 11 mmHg |
Primary outcome
Change in six minute walk distance in meters at 6 months
Time frame: 6 months +/- 15 days after enrollment
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.
5 secondary outcomes
Change Walking Impairment Questionairre (WIQ)Score at 6 months
Time frame: 6 months +/- 15 days after enrollment
Change in Ankle Brachial Index (ABI) at 6 months
Time frame: 6months +/- 15 days after enrollment
Change in six minute walk distance from baseline to within 2 weeks post revascularization
Time frame: baseline pre revascularization to two weeks post measurement
Change in WIQ score from baseline to within 2 weeks post revascularization
Time frame: 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
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Background: PubMed 24753020Klein 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.
- Background: PubMed 21891804Walker C. What is the role of translesional pressure gradient measurement in peripheral intervention? J Invasive Cardiol. 2011 Sep;23(9):357. No abstract available.
- Background: PubMed 8043361Archie 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.
- Background: PubMed 21891803Banerjee 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.
- Background: PubMed 17300406Garcia 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.
- Background: PubMed 17084261De 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.
- Background: PubMed 12719196Belch 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.
- Background: PubMed 8816537Tetteroo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Claudication, run by North Texas Veterans Healthcare System at 1 site in United States.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in six minute walk distance in meters at 6 months (time frame: 6 months +/- 15 days after enrollment). 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 NCT02387658, which also lists 8 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 12 Sep 2018.