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

NCT02037113 | Terminated DMC

• 1 other identifier: L14-047
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 1.To determine intravascular ultrasound parameters of stent deployment and outcomes of Femoro-popliteal Disease
2. 2.To determine clinical risk factors and outcomes of Femoro-popliteal Disease
3. 3.To obtain data that will eventually support development of a predictive model for ISR in Femoro-popliteal Disease

Conditions

Peripheral Arterial Disease

Keywords

IVUS; PAD; Femoro-popliteal disease; Intravascular ultrasound

Outcome Measures

Primary Outcomes (4)

• In Stent Restenosis

  1 years

• Redo procedure

  1 year

• Early and late stent thrombosis

  1 year

• Acute ischemic event

  1 year

Secondary Outcomes (1)

• All causes mortality

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 25 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Related Publications (7)

• 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.

  PMID: 2950322 BACKGROUND

• 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.

  PMID: 16616230 BACKGROUND

• 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.

  PMID: 9293832 BACKGROUND

• 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.

  PMID: 9152310 BACKGROUND

• 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.

  PMID: 9068134 BACKGROUND

• 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.

  PMID: 23535039 BACKGROUND

• 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.

  PMID: 16672699 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Alex Suarez, MD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 21, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)