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

NCT01230229 | Completed

• 1 other identifier: SFA stenting and QoL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (1)

• Ankle/Brachial Index (ABI) and Walking Distance

  24 months

Study Arms (2)

Stenting

ACTIVE COMPARATOR

Active treatment group

Procedure: Stenting

Conservative treatment

PLACEBO COMPARATOR

Best medical treatment

Other: Best medical treatment

Interventions

Stenting PROCEDURE

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.

Also known as: Endovascular treatment of claudication

Stenting

Best medical treatment OTHER

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.

Also known as: Medical treatment of intermittent claudication

Conservative treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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.
• Walking capacity more than 500 meters.

Sponsors & Collaborators

• Lund University: lead

Study Sites (2)

Dept of Radiology, Helsingborg Hospital

Helsingborg, S-251 87, Sweden

Location

Department of Vascular Disease, Skåne University Hospital

Malmo, S-205 02, Sweden

Location

Related Publications (2)

• 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.

  PMID: 28372983 RESULT

• 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.

  PMID: 29520431 DERIVED

MeSH Terms

Conditions

Intermittent Claudication

Interventions

Stents

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Hans Lindgren, MD

  Dept of Radiology, Helsingborg Hospital, Helsingborg, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: October 29, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 23, 2017

Record last verified: 2017-08

Locations

SE (2)