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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Lund University
Sponsor:
Information provided by (Responsible Party):
Anders Gottsater, Lund University
ClinicalTrials.gov Identifier:
NCT01230229
First received: October 28, 2010
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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. So far (May 2014) 82 patients have been randomized.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary Stenting vs Conservative Treatment in Claudicants - a Study on Quality of Life

Further study details as provided by Lund University:

Primary Outcome Measures:
  • Improvement in Quality of Life scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230229

Contacts
Contact: Hans Lindgren, MD 00 46 733 148580 2hanslindgren@gmail.com
Contact: Anders Gottsäter, MD, PhD 00 46 40 338076 anders.gottsater@med.lu.se

Locations
Sweden
Dept of Radiology, Helsingborg Hospital Recruiting
Helsingborg, Sweden, S-251 87
Contact: Hans Lindgren, MD    00 46 733 148 580    2hanslindgren@gmail.com   
Principal Investigator: Hans Lindgren, MD         
Sub-Investigator: Peter Qvarfordt, MD PhD         
Department of Vascular Disease, Skåne University Hospital Recruiting
Malmö, Sweden, S-205 02
Contact: Anders Gottsäter, MD, PhD    00 46 40 338076    anders.gottsater@med.lu.se   
Principal Investigator: Anders Gottsäter, MD, PhD         
Sub-Investigator: Michael Åkesson, MD         
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Hans Lindgren, MD Dept of Radiology, Helsingborg Hospital, Helsingborg, Sweden
  More Information

No publications provided

Responsible Party: Anders Gottsater, MD, PhD, Lund University
ClinicalTrials.gov Identifier: NCT01230229     History of Changes
Other Study ID Numbers: SFA stenting and QoL
Study First Received: October 28, 2010
Last Updated: May 28, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Lund University:
Intermittent claudication
Superficial femoral artery
Stenting
Medical treatment
Quality of life

ClinicalTrials.gov processed this record on October 23, 2014