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

NCT01230229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-08-23

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • Lund University

    lead OTHER

Principal Investigators

  • Hans Lindgren, MD · Dept of Radiology, Helsingborg Hospital, Helsingborg, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2017-07-31
Completion
2017-08-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01230229 on ClinicalTrials.gov