Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance (IVUS-PAD)
Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance (CRI14-007)
This is a prospective, single-center study. The patients with peripheral arterial disease who underwent abdominal aortograms with runoff (which are arteriograms of the lower abdominal aorta and arteries in the legs) and Intravascular Ultrasound after stent deployment will be enrolled in the study. All patients who participated in the study will be treated according to standard of care.
HYPOTHESIS The higher degree of plaque burden on landing zone has an effect on restenosis on peripheral artery intervention.
SPECIFIC AIMS
- To determine intravascular ultrasound parameters of stent deployment and outcomes of Femoro-popliteal Disease
- To determine clinical risk factors and outcomes of Femoro-popliteal Disease
- 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
SUBJECT POPULATION:
- 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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Texas
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Lubbock, Texas, Stati Uniti, 79430
- Texas Tech University Health Sciences Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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In Stent Restenosis
Lasso di tempo: 1 years
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1 years
|
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Redo procedure
Lasso di tempo: 1 year
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1 year
|
|
Early and late stent thrombosis
Lasso di tempo: 1 year
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1 year
|
|
Acute ischemic event
Lasso di tempo: 1 year
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1 year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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All causes mortality
Lasso di tempo: 1 year
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to be obtained from UMC Cath-Lab NCDR registry
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1 year
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Alex Suarez, MD, Texas Tech University Health Sciences Center
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- L14-047
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