Determining Predictors of Restenosis in Femoropopliteal Lesions

Determining Predictors of Restenosis. Intravascular Ultrasound in the Treatment of Femoropopliteal Lesions

A prospective, single-center, real-world study on intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.

Study Overview

• Status: Unknown
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Device: Ultrasound

Detailed Description

Intravascular ultrasound is considered important tool in endovascular procedures of coronary territory. Information such as vessel diameter, stent expansion, residual stenosis, helped in better understanding of the disease, treatment and stent behavior.

However, as a different anatomical territory with major hemodynamic differences, many of these concepts could not be reproduced in the femoropopliteal segment.

The purpose of this study is to correlate data collected by intraoperative intravascular ultrasound after the angioplasty procedure with stent placement in femoropopliteal arterial lesions and patency of this revascularization within 12 months.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Stenotic (>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries;
• Successful lesion passage passed with conventional mechanical guidewires;
• Symptomatic critical limb ischemia (Rutherford 4, 5, 6);
• Life-expectancy of more than 12 months;
• Tha patient must be willing and able to return to the appropriate follow-up times for the duration of the study;
• Te patient must provide written patient informed consent that is approved by the ethics committee.

Exclusion Criteria:

• Patient refusing treatment;
• The reference segment diameter is not suitable fo available balloon and/or stent design;
• Unsuccessfully treated (>30% residual stenosis) proximal inflow limiting arterial stenosis;
• Previously implanted stent(s) or percutaneous transluminal angioplasty at the same lesion site;
• The patient has a known allergy to heparin, Aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies;
• The patent has a history of prior life-threatening contrast media reaction;
• The patient is currently enrolled in another investigational device or drug trial;
• The patient is currently breast-feeding, pregnant or intends to become pregnant;
• The patient is mentally ill or retarded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravascular Ultrasound data; Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.	Device: Ultrasound; Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Burden Measure	defined as = (external elastic membrane cross-sectional area - lumen cross-sectional area) ÷ external elastic membrane cross-sectional area	intraoperative
Reference Lumen Measure	defined as = (proximal reference lumen cross-sectional area + distal reference lumen cross-sectional area) x 0.5	intraoperative
Reference Diameter Measure	defined as = (proximal reference diameter + distal reference diameter) x 0.5	intraoperative
Stent/reference Diameter Ratio Measure	defined as = stent diameter ÷ reference diameter	intraoperative
Stent Expansion Ratio Measure	defined as = minimum stent cross-sectional area ÷ reference lumen cross-sectional area	intraoperative
Radial Stent Symmetry Index Measure	defined as = minimum ÷ maximum stent diameter at minimum stent cross-sectional area	intraoperative
Axial Stent Symmetry Index Measure	defined as = minimum ÷ maximum stent cross-sectional area	intraoperative
In Stent Restenosis		12 months (±30 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater tha 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging.	intraoperative
Freedom of reintervention at each follow-up	defined as freedom from target lesion revascularization (TLR)	Baseline
Freedom of reintervention at each follow-up	defined as freedom from target lesion revascularization (TLR)	1 month (± 7 days)
Freedom of reintervention at each follow-up	defined as freedom from target lesion revascularization (TLR)	3 months (±30 days)
Freedom of reintervention at each follow-up	defined as freedom from target lesion revascularization (TLR)	6 months (±30 days)
Freedom of reintervention at each follow-up	defined as freedom from target lesion revascularization (TLR)	12 months (±30 days)
Limb-salvage rate	defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot)	Baseline
Limb-salvage rate	defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot)	1 month (± 7 days)
Limb-salvage rate	defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot)	3 months (±30 days)
Limb-salvage rate	defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot)	6 months (±30 days)
Limb-salvage rate	defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot)	12 months (±30 days)
Serious adverse events	defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.	Baseline
Serious adverse events	defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.	1 month (± 7 days)
Serious adverse events	defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.	3 months (±30 days)
Serious adverse events	defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.	6 months (±30 days)
Serious adverse events	defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.	12 months (±30 days)
Clinical success at follow-up	defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.	Baseline
Clinical success at follow-up	defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.	1 month (± 7 days)
Clinical success at follow-up	defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.	3 months (±30 days)
Clinical success at follow-up	defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.	6 months (±30 days)
Clinical success at follow-up	defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.	12 months (±30 days)

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Martin A Geiger, MD, University of Campinas, Brazil

Publications and helpful links

General Publications

• Gray BH, Olin JW. Limitations of percutaneous transluminal angioplasty with stenting for femoropopliteal arterial occlusive disease. Semin Vasc Surg. 1997 Mar;10(1):8-16.
• Bosiers M, Torsello G, Gissler HM, Ruef J, Muller-Hulsbeck S, Jahnke T, Peeters P, Daenens K, Lammer J, Schroe H, Mathias K, Koppensteiner R, Vermassen F, Scheinert D. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther. 2009 Jun;16(3):261-9. doi: 10.1583/08-2676.1.
• DOTTER CT, JUDKINS MP. TRANSLUMINAL TREATMENT OF ARTERIOSCLEROTIC OBSTRUCTION. DESCRIPTION OF A NEW TECHNIC AND A PRELIMINARY REPORT OF ITS APPLICATION. Circulation. 1964 Nov;30:654-70. doi: 10.1161/01.cir.30.5.654. No abstract available.
• Dettinger GB. Defending the military family. Am J Psychiatry. 1979 Jun;136(6):855-6. doi: 10.1176/ajp.136.6.855. No abstract available.
• Pentecost MJ, Criqui MH, Dorros G, Goldstone J, Johnston KW, Martin EC, Ring EJ, Spies JB. Guidelines for peripheral percutaneous transluminal angioplasty of the abdominal aorta and lower extremity vessels. A statement for health professionals from a special writing group of the Councils on Cardiovascular Radiology, Arteriosclerosis, Cardio-Thoracic and Vascular Surgery, Clinical Cardiology, and Epidemiology and Prevention, the American Heart Association. Circulation. 1994 Jan;89(1):511-31. doi: 10.1161/01.cir.89.1.511. No abstract available.
• Martin EC, Katzen BT, Benenati JF, Diethrich EB, Dorros G, Graor RA, Horton KM, Iannone LA, Isner JM, Ramee SR, et al. Multicenter trial of the wallstent in the iliac and femoral arteries. J Vasc Interv Radiol. 1995 Nov-Dec;6(6):843-9. doi: 10.1016/s1051-0443(95)71198-8.
• Lammer J, Dake MD, Bleyn J, Katzen BT, Cejna M, Piquet P, Becker GJ, Settlage RA. Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent-graft. International Trial Study Group. Radiology. 2000 Oct;217(1):95-104. doi: 10.1148/radiology.217.1.r00se0595.
• Ferreira M, Lanziotti L, Monteiro M, Abuhadba G, Capotorto LF, Nolte L, Fearnot N. Superficial femoral artery recanalization with self-expanding nitinol stents: long-term follow-up results. Eur J Vasc Endovasc Surg. 2007 Dec;34(6):702-8. doi: 10.1016/j.ejvs.2007.07.025. Epub 2007 Oct 24.
• Laird JR, Jain A, Zeller T, Feldman R, Scheinert D, Popma JJ, Armstrong EJ, Jaff MR; Complete SE Investigators. Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial. J Endovasc Ther. 2014 Apr;21(2):202-12. doi: 10.1583/13-4548R.1.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Estimate): April 12, 2016
• Last Update Submitted That Met QC Criteria: April 11, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 52994416.7.0000.5404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED