Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance
NCT ID: NCT02037113
Last Updated: 2018-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
8 participants
OBSERVATIONAL
2014-01-31
2016-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
HYPOTHESIS The higher degree of plaque burden on landing zone has an effect on restenosis on peripheral artery intervention.
SPECIFIC AIMS
1. To determine intravascular ultrasound parameters of stent deployment and outcomes of Femoro-popliteal Disease
2. To determine clinical risk factors and outcomes of Femoro-popliteal Disease
3. To obtain data that will eventually support development of a predictive model for ISR in Femoro-popliteal Disease
METHODOLOGY Visit 1: After consent is given
The subject will receive standard follow-up care. A member of the research team will collect information such as the subject's age, sex, ethnicity, and medical information from the subject's medical record.
Visits 2-5: 1 day after enrollment, and at months 3 (+- 2 weeks), 6 (+- 2 weeks), and 12 (+- 2 weeks)
The subject will complete standard follow-up appointment at TTUHSC. This may include a Doppler ultrasound.
A member of the research team will record information such as medications, ultrasounds, and need for additional care related to the subject's stent.
The subject will complete the questionnaire on leg pain and mobility.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optimal Stent Selection for the Femoropopliteal Artery
NCT02602145
Below Study - Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee
NCT00163254
Vessel Deformations and Restenosis After Stenting of the Popliteal Artery
NCT04700371
Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization
NCT06387355
Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion
NCT03121430
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
\- The patients who have peripheral arterial disease and underwent elective abdominal aortograms with runoff with peripheral artery intervention in University Medical Center hospital, Lubbock Texas, during January 2014 to December 30, 2015.
INCLUSION CRITERIA:
* 25-89 years of age
* Admitted for elective abdominal aortograms with runoff.
* Underwent Angioplasty and/or atherectomy with stent placement for Femoro-popliteal disease.
* Intravascular ultrasound was performed after stent deployment.
EXCLUSION CRITERIA:
* Patients who had prior Femoro-popliteal artery surgery or bypass in the same limb.
* Stent placement for lesions above inguinal ligament or below popliteal artery.
* The patient who presented with acute limb ischemia.
* Unable to follow-up in TTUHSC clinic.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patient underwent PAD-Stent
Patient who underwent angioplasty and/or atherectomy with stent placement for Femoro-popliteal disease and Intravascular ultrasound was performed after stent deployment.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Admitted for elective abdominal aortograms with runoff.
* Underwent Angioplasty and/or atherectomy with stent placement for Femoro-popliteal disease.
* Intravascular ultrasound was performed after stent deployment.
Exclusion Criteria
* Stent placement for lesions above inguinal ligament or below popliteal artery.
* The patient who presented with acute limb ischemia.
* Unable to follow-up in TTUHSC clinic.
25 Years
89 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Texas Tech University Health Sciences Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alex Suarez, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Tech University Health Sciences Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.
Conte MS, Bandyk DF, Clowes AW, Moneta GL, Seely L, Lorenz TJ, Namini H, Hamdan AD, Roddy SP, Belkin M, Berceli SA, DeMasi RJ, Samson RH, Berman SS; PREVENT III Investigators. Results of PREVENT III: a multicenter, randomized trial of edifoligide for the prevention of vein graft failure in lower extremity bypass surgery. J Vasc Surg. 2006 Apr;43(4):742-751; discussion 751. doi: 10.1016/j.jvs.2005.12.058.
Reifsnyder T, Grossman JP, Leers SA. Limb loss after lower extremity bypass. Am J Surg. 1997 Aug;174(2):149-51. doi: 10.1016/s0002-9610(97)90074-x.
Sullivan TM, Childs MB, Bacharach JM, Gray BH, Piedmonte MR. Percutaneous transluminal angioplasty and primary stenting of the iliac arteries in 288 patients. J Vasc Surg. 1997 May;25(5):829-38; discussion 838-9. doi: 10.1016/s0741-5214(97)70212-x.
Martinez R, Rodriguez-Lopez J, Diethrich EB. Stenting for abdominal aortic occlusive disease. Long-term results. Tex Heart Inst J. 1997;24(1):15-22.
Leon LR Jr, Dieter RS, Gadd CL, Ranellone E, Mills JL Sr, Montero-Baker MF, Gruessner AC, Pacanowski JP Jr. Preliminary results of the initial United States experience with the Supera woven nitinol stent in the popliteal artery. J Vasc Surg. 2013 Apr;57(4):1014-22. doi: 10.1016/j.jvs.2012.10.093.
Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
L14-047
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.