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Primary Stenting vs Conservative Treatment in Claudicants - a Study on Quality of Life

Primary Purpose

Stable Claudication (Fontaine IIa and IIb), Superficial Femoral Artery Disease, Best Medical Treatment

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Stenting
Best medical treatment
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Claudication (Fontaine IIa and IIb) focused on measuring Intermittent claudication, Superficial femoral artery, Stenting, Medical treatment, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age > 18 years
  2. Female patients with child bearing potential may not be pregnant at study entry and must utilize reliable birth control for the duration of their participation in the study.
  3. Patient suffering from stable claudication (Fontaine IIa and IIb).
  4. One de-novo or restenotic superficial femoral artery with the target treatment area not extending beyond approximately 3 cm above the patella at MRA.
  5. Patent popliteal artery on the index side, and runoff vessel situation at level six or better according to Rutherford classification prior to the day of the procedure. Target vessel diameter ≥ 4 mm at MRA.
  6. Patient is willing and able to comply with the specified follow-up evaluation
  7. The patient or legally authorized representative must provide written informed consent prior to the procedure.

Exclusion Criteria:

  1. Recent hemorrhagic stroke (within past 3 months)
  2. Aneurysm in the SFA or popliteal artery
  3. Previously implanted stent(s) in the to be treated artery at the same site
  4. Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft. However, intervention to restore adequate blood flow at least three months prior to the index procedure is allowed
  5. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device
  6. Revascularisation involving the same limb 30 days prior to the index procedure or a planned revascularisation within 30 days after the index procedure

8.Critical Limb Ischemia in the index leg (Fontaine III and IV). 9.Requirement of stent placement in the popliteal artery. For the purpose of this protocol all lesions are to be located at least three centimetres proximal to the superior edge of the patella.

10.Life expectancy of less than 24 months or other factors making clinical follow-up difficult 11.Patients enrolled in this or other clinical trial or anticipated to be included into a trial, without written approval of principal investigator of this study.

12.Walking capacity more than 500 meters.

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Sites / Locations

  • Dept of Radiology, Helsingborg Hospital
  • Department of Vascular Disease, Skåne University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Stenting

Conservative treatment

Arm Description

Active treatment group

Best medical treatment

Outcomes

Primary Outcome Measures

Improvement in Quality of Life scores
Improvement in Quality of Life scores at 12 months after treatment using SF-36 and EuroQol EQ-5D surveys

Secondary Outcome Measures

Ankle/Brachial Index (ABI) and Walking Distance
Ankle/Brachial Index (ABI) and walking distance development during the follow up period. In addition, cost-parameters will be collected in each arm to allow for basic cost-effectiveness comparisons after 24 months.

Full Information

First Posted
October 28, 2010
Last Updated
August 22, 2017
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT01230229
Brief Title
Primary Stenting vs Conservative Treatment in Claudicants - a Study on Quality of Life
Official Title
Primary Stenting vs Conservative Treatment in Claudicants - a Study on Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate whether primary stenting with self expanding stent in patients with peripheral arterial disease suffering from stable claudication due to superficial femoral artery disease results in improved patient outcomes, compared to conservative treatment alone as measured by improvement in Quality of Life scores at 12 months after treatment using established surveys. Patients will be followed up 24 months after treatment. Planned recruitment and randomization of 100 patients was completed June 2015.
Detailed Description
Occlusive disease of the femoro-popliteal arteries is associated with symptoms ranging from pain in the calf on exertion to pain at rest and ultimately ulceration and gangrene. Treatment options include a) conservative measures, with attention to medical risk factors, smoking cessation and exercise programmes, b) minimally invasive treatments such as angioplasty and c) surgical procedures such as femoro-popliteal bypass grafts. Percutaneous transluminal angioplasty (PTA) has been widely used in the treatment of femoro-popliteal stenosis and occlusion for many years. However, the medium and long-term results have always been suboptimal due to a high rate of restenosis. With restenosis rates of 70 % with PTA alone in long SFA lesions. Factors which contribute to poor results include the presence of occlusion rather than stenosis, the length of the lesion and the severity of run-off vessel disease.(1) Stents are expandable metal mesh tubes which are widely used in the treatment of arterial disease in the coronary, renal and iliac arteries, where they have been shown to have superior patency to balloon angioplasty alone. In the treatment of SFA lesions several early studies have investigated the patency of balloon expandable stents. These are stents with low flexibility and high risk of deformation in SFA. Medium and long-term results are not better than with PTA alone.(2) Self expanding nitinol stents are stents generally with high flexibility and moderate to high radial force. Initial studies have shown promising results in the SFA.(3) Early prospective randomised studies , the Sirocco I and II study show as low as 7 % restenosis rate at 6 months and 18% at 12 months self expanding nitinol stent.(4, 5) Later studies have focused on the issue of the correlation of stent fractures and low patency. These have shown that higher restenosis rates correlated to the length of the stented segment, number of stents and stent brand (6) Up to now the most frequent use of stents in the SFA is "bailout" stenting. Investigated in a prospective randomised trial on patients with severe claudication or critical ischemia with long lesions (130 +- 60 mm) primary stenting in the SFA is showing superior results to PTA with bailout stenting on restenosis rate, ABI and walking distance.(7) There are for the moment two more trials investigating the results of direct stenting. The FAST trial investigated claudicants with short lesions (4,5 cm); the stent arm used Luminexx stents versus PTA alone with no significant in difference in patency between both treatment arms after 12 months follow up.(8) The Resilient trial investigated patients with claudication and critical limb ischemia with 6,5 cm long lesions. The results are not published, but positive "pre hand" information has already come out. (9) The most accepted treatment in claudicants is conservative best medical treatment with or without supervised walking training.(10) There is a trend to stent treatment in certain situations. There are to the best of our knowledge no studies comparing direct stenting with conservative treatment in claudicants. The aim of this study is to evaluate whether primary stenting with nitinol self expanding stent in patients suffering from stable claudication (Fontaine IIa and IIb) due to superficial femoral artery disease, results in improved patient outcomes, compared to conservative treatment alone as measured by improvement in Quality of Life scores at 12 months after treatment using SF-36 and EuroQol EQ-5D surveys. Patients will be followed up 24 months after treatment. A secondary objective is to study the impact of primary stenting versus conservative treatment on ABI and Walking Distance development during the 24 month follow up period. In addition, cost-parameters will be collected in each arm to allow for basic cost-effectiveness comparisons after 24 months. 12 month follow-up data have been published in Eur J Vasc Endovasc Surg 2017;53:686-694. All 24 month follow-up data have been collected, and a manuscript is in preparation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Claudication (Fontaine IIa and IIb), Superficial Femoral Artery Disease, Best Medical Treatment, Quality of Life Scores at 12 and 24 Months
Keywords
Intermittent claudication, Superficial femoral artery, Stenting, Medical treatment, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stenting
Arm Type
Active Comparator
Arm Description
Active treatment group
Arm Title
Conservative treatment
Arm Type
Placebo Comparator
Arm Description
Best medical treatment
Intervention Type
Procedure
Intervention Name(s)
Stenting
Other Intervention Name(s)
Endovascular treatment of claudication
Intervention Description
The stent should be deployed percutaneously, appropriate stent(s) size selected based upon the angiogram. The diameter must be 1-2 mm larger than the vessel. Length is chosen to cover lesion with one stent if possible. The choice of brand will be made through random selection among those offering possibility to cover the lesion with one stent. If more than one stent is required, overlap between 0.5 and 1 cm is acceptable. Postdilatation must be performed with a PTA balloon shorter than the length and less than the diameter of the stent. An angiogram should be made to compare the pre- and post-implant minimum lumen diameters. The non-diseased artery diameters shall be measured and residual % stenosis calculated.
Intervention Type
Other
Intervention Name(s)
Best medical treatment
Other Intervention Name(s)
Medical treatment of intermittent claudication
Intervention Description
Patients randomised to conservative treatment will receive appropriate medication with target levels of cholesterol 4,5 mmol/l, LDL 2,5 mmol/l and blood pressure level of 130/80 mmHg in addition to instruction how to engage in an exercise program. Each patient will receive a 'step-meter' which has to be carried during all activity during the first month and then during one week before each follow up visit. Step-meter read-outs will be recorded during each follow up visit. Smokers will be actively advised to quit smoking.
Primary Outcome Measure Information:
Title
Improvement in Quality of Life scores
Description
Improvement in Quality of Life scores at 12 months after treatment using SF-36 and EuroQol EQ-5D surveys
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Ankle/Brachial Index (ABI) and Walking Distance
Description
Ankle/Brachial Index (ABI) and walking distance development during the follow up period. In addition, cost-parameters will be collected in each arm to allow for basic cost-effectiveness comparisons after 24 months.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years Female patients with child bearing potential may not be pregnant at study entry and must utilize reliable birth control for the duration of their participation in the study. Patient suffering from stable claudication (Fontaine IIa and IIb). One de-novo or restenotic superficial femoral artery with the target treatment area not extending beyond approximately 3 cm above the patella at MRA. Patent popliteal artery on the index side, and runoff vessel situation at level six or better according to Rutherford classification prior to the day of the procedure. Target vessel diameter ≥ 4 mm at MRA. Patient is willing and able to comply with the specified follow-up evaluation The patient or legally authorized representative must provide written informed consent prior to the procedure. Exclusion Criteria: Recent hemorrhagic stroke (within past 3 months) Aneurysm in the SFA or popliteal artery Previously implanted stent(s) in the to be treated artery at the same site Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft. However, intervention to restore adequate blood flow at least three months prior to the index procedure is allowed Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device Revascularisation involving the same limb 30 days prior to the index procedure or a planned revascularisation within 30 days after the index procedure 8.Critical Limb Ischemia in the index leg (Fontaine III and IV). 9.Requirement of stent placement in the popliteal artery. For the purpose of this protocol all lesions are to be located at least three centimetres proximal to the superior edge of the patella. 10.Life expectancy of less than 24 months or other factors making clinical follow-up difficult 11.Patients enrolled in this or other clinical trial or anticipated to be included into a trial, without written approval of principal investigator of this study. 12.Walking capacity more than 500 meters. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Lindgren, MD
Organizational Affiliation
Dept of Radiology, Helsingborg Hospital, Helsingborg, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Radiology, Helsingborg Hospital
City
Helsingborg
ZIP/Postal Code
S-251 87
Country
Sweden
Facility Name
Department of Vascular Disease, Skåne University Hospital
City
Malmö
ZIP/Postal Code
S-205 02
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
28372983
Citation
Lindgren H, Qvarfordt P, Akesson M, Bergman S, Gottsater A; Swedish Endovascular Claudication Stenting Trialists. Primary Stenting of the Superficial Femoral Artery in Intermittent Claudication Improves Health Related Quality of Life, ABI and Walking Distance: 12 Month Results of a Controlled Randomised Multicentre Trial. Eur J Vasc Endovasc Surg. 2017 May;53(5):686-694. doi: 10.1016/j.ejvs.2017.01.026. Epub 2017 Mar 31.
Results Reference
result
PubMed Identifier
29520431
Citation
Lindgren HIV, Qvarfordt P, Bergman S, Gottsater A; Swedish Endovascular Claudication Stenting Trialists. Primary Stenting of the Superficial Femoral Artery in Patients with Intermittent Claudication Has Durable Effects on Health-Related Quality of Life at 24 Months: Results of a Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2018 Jun;41(6):872-881. doi: 10.1007/s00270-018-1925-0. Epub 2018 Mar 8.
Results Reference
derived

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Primary Stenting vs Conservative Treatment in Claudicants - a Study on Quality of Life

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