Determining Predictors of Restenosis in Femoropopliteal Lesions

Peripheral Vascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02734095
• Other study ID #: 52994416.7.0000.5404
• Status: Not yet recruiting
• Phase: N/A
• First received: March 23, 2016
• Last updated: April 11, 2016
• Start date: August 2016
• Est. completion date: September 2018

Study information

• Verified date: April 2016
• Source: University of Campinas, Brazil
• Contact: Martin A Geiger, MD
• Phone: +55 19 35218936
• Email: martinandreasgeiger[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Ultrasound
Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Fundação de Amparo à Pesquisa do Estado de São Paulo

References & Publications (9)

Bosiers M, Torsello G, Gissler HM, Ruef J, Müller-Hülsbeck S, Jahnke T, Peeters P, Daenens K, Lammer J, Schroë 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. — View Citation

Dettinger GB. Defending the military family. Am J Psychiatry. 1979 Jun;136(6):855-6. — View Citation

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. — View Citation

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. Epub 2007 Oct 24. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Burden Measure	defined as = (external elastic membrane cross-sectional area - lumen cross-sectional area) ÷ external elastic membrane cross-sectional area	intraoperative	Yes
Primary	Reference Lumen Measure	defined as = (proximal reference lumen cross-sectional area + distal reference lumen cross-sectional area) x 0.5	intraoperative	Yes
Primary	Reference Diameter Measure	defined as = (proximal reference diameter + distal reference diameter) x 0.5	intraoperative	Yes
Primary	Stent/reference Diameter Ratio Measure	defined as = stent diameter ÷ reference diameter	intraoperative	Yes
Primary	Stent Expansion Ratio Measure	defined as = minimum stent cross-sectional area ÷ reference lumen cross-sectional area	intraoperative	Yes
Primary	Radial Stent Symmetry Index Measure	defined as = minimum ÷ maximum stent diameter at minimum stent cross-sectional area	intraoperative	Yes
Primary	Axial Stent Symmetry Index Measure	defined as = minimum ÷ maximum stent cross-sectional area	intraoperative	Yes
Primary	In Stent Restenosis		12 months (±30 days)	Yes
Secondary	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	Yes
Secondary	Freedom of reintervention at each follow-up	defined as freedom from target lesion revascularization (TLR)	Baseline	Yes
Secondary	Freedom of reintervention at each follow-up	defined as freedom from target lesion revascularization (TLR)	1 month (± 7 days)	Yes
Secondary	Freedom of reintervention at each follow-up	defined as freedom from target lesion revascularization (TLR)	3 months (±30 days)	Yes
Secondary	Freedom of reintervention at each follow-up	defined as freedom from target lesion revascularization (TLR)	6 months (±30 days)	Yes
Secondary	Freedom of reintervention at each follow-up	defined as freedom from target lesion revascularization (TLR)	12 months (±30 days)	Yes
Secondary	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	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No