Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance

Peripheral Arterial Disease Clinical Trial

— IVUS-PAD  

Official title:

Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance (CRI14-007)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02037113
• Other study ID #: L14-047
• Status: Terminated
• First received: January 13, 2014
• Last updated: March 19, 2018
• Start date: January 2014
• Est. completion date: August 2016

Study information

• Verified date: March 2018
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

León 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. — View Citation

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. — View Citation

Reifsnyder T, Grossman JP, Leers SA. Limb loss after lower extremity bypass. Am J Surg. 1997 Aug;174(2):149-51. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In Stent Restenosis		1 years
Primary	Redo procedure		1 year
Primary	Early and late stent thrombosis		1 year
Primary	Acute ischemic event		1 year
Secondary	All causes mortality	to be obtained from UMC Cath-Lab NCDR registry	1 year