Prospective Observation Study of Cost Effectiveness of Interventions for Critical Ischemia (PROVENCE)
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 life qualifying small after treatment at, respectively one, 12 and 24 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.
Critical Limb Ischemia
Procedure: Bypass surgery
Procedure: Endovascular recanalization
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration:||2 Years|
|Official Title:||Prospective Observation Study of Cost Effectiveness of Interventions for Critical Ischemia|
- Health related cost [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Amputation free survival and Rutherford scale [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Amputation free survival. Rutherford scale:International established scoring system 0-6 for grading of lower limb ischemia.
- Patency of vascular reconstruction. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Primary patancy: Freedom from occlusion of bypass-graft or endovacular treated arterial segment and freedom of restenosis that need intervention in bypass-graft or endovascular treated arterial segment.
Secondary patancy:Freedom from occlusion of bypass-graft or endovacular treated arterial segment. Treated for restenosis in bypass-graft or endovascular treated arterial segment.
- Health related quality of life [ Time Frame: 2 year ] [ Designated as safety issue: No ]Health related quality of life measured by EQ-5D and VASCUQUAL
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Open surgical group
Bypass surgery for critical limb ischemia
|Procedure: Bypass surgery|
Endovascular recanalization for critical limb ischemia
|Procedure: Endovascular recanalization|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794494
|Contact: Klas Österberg, MD.PhDfirstname.lastname@example.org|
|Contact: Angelica Perlander, MDemail@example.com|
|Department of vascular surgery, Sahlgrenska University Hospital||Recruiting|
|Gothenborg, Sweden, 413 45|
|Contact: Angelica Perlander, MD +46313421000 firstname.lastname@example.org|
|Principal Investigator:||Klas Österberg, MD, PhD||Sahlgrenska University Hospital, Sweden|