Prospective Observation Study of Cost Effectiveness of Interventions for Critical Ischemia (PROVENCE)
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|ClinicalTrials.gov Identifier: NCT01794494|
Recruitment Status : Unknown
Verified May 2015 by Klas Osterberg, Sahlgrenska University Hospital, Sweden.
Recruitment status was: Active, not recruiting
First Posted : February 20, 2013
Last Update Posted : May 20, 2015
|Condition or disease||Intervention/treatment|
|Critical Limb Ischemia||Procedure: Bypass surgery Procedure: Endovascular recanalization|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||250 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Prospective Observation Study of Cost Effectiveness of Interventions for Critical Ischemia|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2017|
Open surgical group
Bypass surgery for critical limb ischemia
Procedure: Bypass surgery
Patients are treated with femoro-popliteal bypass
Endovascular recanalization for critical limb ischemia
Procedure: Endovascular recanalization
Patients are treated with PTA or subintimal angioplasty
- Health related cost [ Time Frame: 2 years ]
- Amputation free survival and Rutherford scale [ Time Frame: 2 Years ]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 ]
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 ]Health related quality of life measured by EQ-5D and VASCUQUAL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794494
|Department of vascular surgery, Sahlgrenska University Hospital|
|Gothenborg, Sweden, 413 45|
|Principal Investigator:||Klas Österberg, MD, PhD||Sahlgrenska University Hospital, Sweden|