Back to resultsDetermining Predictors of Restenosis in Femoropopliteal Lesions
Primary Purpose
Peripheral Vascular Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Peripheral Vascular Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intravascular Ultrasound data
Arm Description
Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.
Outcomes
Primary Outcome Measures
Plaque Burden Measure
defined as = (external elastic membrane cross-sectional area - lumen cross-sectional area) ÷ external elastic membrane cross-sectional area
Reference Lumen Measure
defined as = (proximal reference lumen cross-sectional area + distal reference lumen cross-sectional area) x 0.5
Reference Diameter Measure
defined as = (proximal reference diameter + distal reference diameter) x 0.5
Stent/reference Diameter Ratio Measure
defined as = stent diameter ÷ reference diameter
Stent Expansion Ratio Measure
defined as = minimum stent cross-sectional area ÷ reference lumen cross-sectional area
Radial Stent Symmetry Index Measure
defined as = minimum ÷ maximum stent diameter at minimum stent cross-sectional area
Axial Stent Symmetry Index Measure
defined as = minimum ÷ maximum stent cross-sectional area
In Stent Restenosis
Secondary Outcome Measures
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.
Freedom of reintervention at each follow-up
defined as freedom from target lesion revascularization (TLR)
Freedom of reintervention at each follow-up
defined as freedom from target lesion revascularization (TLR)
Freedom of reintervention at each follow-up
defined as freedom from target lesion revascularization (TLR)
Freedom of reintervention at each follow-up
defined as freedom from target lesion revascularization (TLR)
Freedom of reintervention at each follow-up
defined as freedom from target lesion revascularization (TLR)
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)
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)
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)
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02734095
First Posted
March 23, 2016
Last Updated
April 11, 2016
Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02734095
Brief Title
Determining Predictors of Restenosis in Femoropopliteal Lesions
Official Title
Determining Predictors of Restenosis. Intravascular Ultrasound in the Treatment of Femoropopliteal Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A prospective, single-center, real-world study on intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravascular Ultrasound data
Arm Type
Experimental
Arm Description
Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.
Primary Outcome Measure Information:
Title
Plaque Burden Measure
Description
defined as = (external elastic membrane cross-sectional area - lumen cross-sectional area) ÷ external elastic membrane cross-sectional area
Time Frame
intraoperative
Title
Reference Lumen Measure
Description
defined as = (proximal reference lumen cross-sectional area + distal reference lumen cross-sectional area) x 0.5
Time Frame
intraoperative
Title
Reference Diameter Measure
Description
defined as = (proximal reference diameter + distal reference diameter) x 0.5
Time Frame
intraoperative
Title
Stent/reference Diameter Ratio Measure
Description
defined as = stent diameter ÷ reference diameter
Time Frame
intraoperative
Title
Stent Expansion Ratio Measure
Description
defined as = minimum stent cross-sectional area ÷ reference lumen cross-sectional area
Time Frame
intraoperative
Title
Radial Stent Symmetry Index Measure
Description
defined as = minimum ÷ maximum stent diameter at minimum stent cross-sectional area
Time Frame
intraoperative
Title
Axial Stent Symmetry Index Measure
Description
defined as = minimum ÷ maximum stent cross-sectional area
Time Frame
intraoperative
Title
In Stent Restenosis
Time Frame
12 months (±30 days)
Secondary Outcome Measure Information:
Title
Technical success
Description
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.
Time Frame
intraoperative
Title
Freedom of reintervention at each follow-up
Description
defined as freedom from target lesion revascularization (TLR)
Time Frame
Baseline
Title
Freedom of reintervention at each follow-up
Description
defined as freedom from target lesion revascularization (TLR)
Time Frame
1 month (± 7 days)
Title
Freedom of reintervention at each follow-up
Description
defined as freedom from target lesion revascularization (TLR)
Time Frame
3 months (±30 days)
Title
Freedom of reintervention at each follow-up
Description
defined as freedom from target lesion revascularization (TLR)
Time Frame
6 months (±30 days)
Title
Freedom of reintervention at each follow-up
Description
defined as freedom from target lesion revascularization (TLR)
Time Frame
12 months (±30 days)
Title
Limb-salvage rate
Description
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)
Time Frame
Baseline
Title
Limb-salvage rate
Description
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)
Time Frame
1 month (± 7 days)
Title
Limb-salvage rate
Description
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)
Time Frame
3 months (±30 days)
Title
Limb-salvage rate
Description
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)
Time Frame
6 months (±30 days)
Title
Limb-salvage rate
Description
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)
Time Frame
12 months (±30 days)
Title
Serious adverse events
Description
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.
Time Frame
Baseline
Title
Serious adverse events
Description
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.
Time Frame
1 month (± 7 days)
Title
Serious adverse events
Description
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.
Time Frame
3 months (±30 days)
Title
Serious adverse events
Description
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.
Time Frame
6 months (±30 days)
Title
Serious adverse events
Description
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.
Time Frame
12 months (±30 days)
Title
Clinical success at follow-up
Description
defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.
Time Frame
Baseline
Title
Clinical success at follow-up
Description
defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.
Time Frame
1 month (± 7 days)
Title
Clinical success at follow-up
Description
defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.
Time Frame
3 months (±30 days)
Title
Clinical success at follow-up
Description
defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.
Time Frame
6 months (±30 days)
Title
Clinical success at follow-up
Description
defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.
Time Frame
12 months (±30 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin A Geiger, MD
Phone
+55 19 35218936
Email
martinandreasgeiger@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin A Geiger, MD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
14226164
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. doi: 10.1161/01.cir.30.5.654. No abstract available.
Results Reference
background
PubMed Identifier
443484
Citation
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.
Results Reference
background
PubMed Identifier
8281692
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. doi: 10.1161/01.cir.89.1.511. No abstract available.
Results Reference
background
PubMed Identifier
8850658
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. doi: 10.1016/s1051-0443(95)71198-8.
Results Reference
background
PubMed Identifier
11012429
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. doi: 10.1148/radiology.217.1.r00se0595.
Results Reference
background
PubMed Identifier
9068071
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.
Results Reference
background
PubMed Identifier
17920306
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. doi: 10.1016/j.ejvs.2007.07.025. Epub 2007 Oct 24.
Results Reference
background
PubMed Identifier
19642788
Citation
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.
Results Reference
background
PubMed Identifier
24754279
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.
Results Reference
background
Learn more about this trial
Determining Predictors of Restenosis in Femoropopliteal Lesions
We'll reach out to this number within 24 hrs