Prospective Observation Study of Cost Effectiveness of Interventions for Critical Ischemia (PROVENCE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Klas Osterberg, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01794494
First received: February 9, 2013
Last updated: May 18, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
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

Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Health related cost [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Estimated Enrollment: 250
Study Start Date: November 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Open surgical group
Bypass surgery for critical limb ischemia
Procedure: Bypass surgery
Patients are treated with femoro-popliteal bypass
Endovascular treatment
Endovascular recanalization for critical limb ischemia
Procedure: Endovascular recanalization
Patients are treated with PTA or subintimal angioplasty

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with critical limb ischemia coming to the for vascular department in the western region of Sweden.

Criteria

Inclusion Criteria:

  • patients with CLI due to arterial occlusion of the superficial femoral artery and popliteal artery being considered for bypass surgery or SAP at any of the four vascular surgical units in VGR.

Exclusion Criteria:

  • patients with CLI due to arterial occlusion of the aorto-iliac arterial segment or distal to the politeal segment.
  • Patients with inability to understand patientinformation and informed concens.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794494

Locations
Sweden
Department of vascular surgery, Sahlgrenska University Hospital
Gothenborg, Sweden, 413 45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Vastra Gotaland Region
Investigators
Principal Investigator: Klas Österberg, MD, PhD Sahlgrenska University Hospital, Sweden
  More Information

Publications:
1.Benartärsjukdom diagnostics and treatment. A systematic literature review. 2007: SBU. Swedish Council on Technology Assessment.
Sullivan M, KJTC, SF-36 Health Survey: Manual and Interpretation Swedish Guide, Second Edition, Göteborg: Sahlgrenska University Hospital

Responsible Party: Klas Osterberg, Dr, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01794494     History of Changes
Other Study ID Numbers: PROVENCE-1
Study First Received: February 9, 2013
Last Updated: May 18, 2015
Health Authority: Sweden: Institutional Review Board

Keywords provided by Sahlgrenska University Hospital, Sweden:
Peripheal arterial disease
Critical limb ischemia
Bypass surgery
Subintimal angioplasty
Health related cost

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on June 30, 2015