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Prospective Observation Study of Outcome of Interventions for Critical Ischemia

NCT01794494 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 190

Last updated 2023-04-21

No results posted yet for this study

Summary

Severe atherosclerosis in the leg arteries is termed critical limb ischemia (CLI). This condition gives great suffering for the patients in terms of pain, wounds and often developing gangrene. Untreated, the condition has a high risk of amputation. In Sweden, the majority of the patients are investigated and evaluated for treatment. Treatment is carried out either by traditional open bypass surgery or balloon dilatation technology (endovascular treatment). The latter method is still under development, and studies have shown that the treatment has less local and systemic complications than bypass surgery. It is also shown that the method has a limitation in that the treatment effect is less durable. What is the role of minimally invasive technologies should have in the future is unclear, mainly due to its efficiency and cost-effectiveness compared with bypass surgery are not evaluated. In a prospective observational study we intend study the effectiveness, cost-effectiveness and impact on quality of life in patients undergoing treatment for critical CLI with bypass surgery or endovascular treatment in Västra Götaland Region (VGR). All patients over a period of two years, which undergo treatment for CLI with either of the two methods will be included in the study. Patients will be followed up with regard to the clinical efficacy and health-related quality of life after treatment at, respectively one, 12 and 24 and 60 months. Cumulative care costs are calculated and estimates of cost are made. This study aims to increase knowledge about the role of endovascular treatment of CLI shall have in the future.

Conditions

  • Critical Limb Ischemia

Interventions

PROCEDURE

Bypass surgery

Patients are treated with femoro-popliteal bypass

PROCEDURE

Endovascular recanalization

Patients are treated with PTA or subintimal angioplasty

Sponsors & Collaborators

  • Vastra Gotaland Region

    collaborator OTHER_GOV

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Klas Österberg, MD, PhD · Sahlgrenska University Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2018-01-31
Completion
2019-01-31

Countries

  • Sweden

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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 NCT01794494 on ClinicalTrials.gov