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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01230229
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : August 23, 2017
Information provided by (Responsible Party):
Anders Gottsater, Lund University

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.

Condition or disease Intervention/treatment Phase
Stable Claudication (Fontaine IIa and IIb) Superficial Femoral Artery Disease Best Medical Treatment Quality of Life Scores at 12 and 24 Months Procedure: Stenting Other: Best medical treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Primary Stenting vs Conservative Treatment in Claudicants - a Study on Quality of Life
Actual Study Start Date : January 2010
Actual Primary Completion Date : July 2017
Actual Study Completion Date : August 2017

Arm Intervention/treatment
Active Comparator: Stenting
Active treatment group
Procedure: Stenting
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.
Other Name: Endovascular treatment of claudication

Placebo Comparator: Conservative treatment
Best medical treatment
Other: Best medical treatment
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.
Other Name: Medical treatment of intermittent claudication

Primary Outcome Measures :
  1. Improvement in Quality of Life scores [ Time Frame: 12 months ]
    Improvement in Quality of Life scores at 12 months after treatment using SF-36 and EuroQol EQ-5D surveys

Secondary Outcome Measures :
  1. Ankle/Brachial Index (ABI) and Walking Distance [ Time Frame: 24 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01230229

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Dept of Radiology, Helsingborg Hospital
Helsingborg, Sweden, S-251 87
Department of Vascular Disease, Skåne University Hospital
Malmö, Sweden, S-205 02
Sponsors and Collaborators
Lund University
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Principal Investigator: Hans Lindgren, MD Dept of Radiology, Helsingborg Hospital, Helsingborg, Sweden
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Anders Gottsater, MD, PhD, Lund University Identifier: NCT01230229    
Other Study ID Numbers: SFA stenting and QoL
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Keywords provided by Anders Gottsater, Lund University:
Intermittent claudication
Superficial femoral artery
Medical treatment
Quality of life
Additional relevant MeSH terms:
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Intermittent Claudication
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms