Prospective Observation Study of Outcome of Interventions for Critical Ischemia

NCT01794494 | Completed

• 1 other identifier: PROVENCE-1
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Peripheal arterial disease; Critical limb ischemia; Bypass surgery; Subintimal angioplasty; Health related cost

Outcome Measures

Primary Outcomes (1)

• Amputation-free survival

  Freedom of death and amputation during the study

  2 years

Secondary Outcomes (1)

• Change in Rutherford scale

  2 Years

Other Outcomes (4)

• Rate of re-intervention

  2 years

• Health related quality of life

  2 years

• Health related quality of life

  2 years

Study Arms (2)

Open surgical group

Bypass surgery for critical limb ischemia

Procedure: Bypass surgery

Endovascular treatment

Endovascular recanalization for critical limb ischemia

Procedure: Endovascular recanalization

Interventions

Bypass surgery PROCEDURE

Patients are treated with femoro-popliteal bypass

Open surgical group

Endovascular recanalization PROCEDURE

Patients are treated with PTA or subintimal angioplasty

Endovascular treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

Department of vascular surgery, Sahlgrenska University Hospital

Gothenborg, 413 45, Sweden

Location

Related Publications (10)

• 1.Benartärsjukdom diagnostics and treatment. A systematic literature review. 2007: SBU. Swedish Council on Technology Assessment.

  BACKGROUND

• Barani J, Mattiasson I, Lindblad B, Gottsater A. Suboptimal treatment of risk factor for atherosclerosis in critical limb ischemia. Int Angiol. 2005 Mar;24(1):59-63.

  PMID: 15877000 BACKGROUND

• Met R, Van Lienden KP, Koelemay MJ, Bipat S, Legemate DA, Reekers JA. Subintimal angioplasty for peripheral arterial occlusive disease: a systematic review. Cardiovasc Intervent Radiol. 2008 Jul-Aug;31(4):687-97. doi: 10.1007/s00270-008-9331-7. Epub 2008 Apr 15.

  PMID: 18414946 BACKGROUND

• Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34. doi: 10.1016/S0140-6736(05)67704-5.

  PMID: 16325694 BACKGROUND

• KUNLIN J. [Long vein transplantation in treatment of ischemia caused by arteritis]. Rev Chir. 1951 Jul-Aug;70(7-8):206-35. No abstract available. Undetermined Language.

  PMID: 14865345 BACKGROUND

• Bolia A, Miles KA, Brennan J, Bell PR. Percutaneous transluminal angioplasty of occlusions of the femoral and popliteal arteries by subintimal dissection. Cardiovasc Intervent Radiol. 1990 Dec;13(6):357-63. doi: 10.1007/BF02578675.

  PMID: 2149672 BACKGROUND

• Diehm N, Pattynama PM, Jaff MR, Cremonesi A, Becker GJ, Hopkins LN, Mahler F, Talen A, Cardella JF, Ramee S, van Sambeek M, Vermassen F, Biamino G. Clinical endpoints in peripheral endovascular revascularization trials: a case for standardized definitions. Eur J Vasc Endovasc Surg. 2008 Oct;36(4):409-19. doi: 10.1016/j.ejvs.2008.06.020. Epub 2008 Aug 8.

  PMID: 18692415 BACKGROUND

• Bjoholt I, Janson M, Jonsson B, Haglind E. Principles for the design of the economic evaluation of COLOR II: an international clinical trial in surgery comparing laparoscopic and open surgery in rectal cancer. Int J Technol Assess Health Care. 2006 Winter;22(1):130-5. doi: 10.1017/s0266462306050926.

  PMID: 16673689 BACKGROUND

• Sullivan M, KJTC, SF-36 Health Survey: Manual and Interpretation Swedish Guide, Second Edition, Göteborg: Sahlgrenska University Hospital

  BACKGROUND

• Morgan MB, Crayford T, Murrin B, Fraser SC. Developing the Vascular Quality of Life Questionnaire: a new disease-specific quality of life measure for use in lower limb ischemia. J Vasc Surg. 2001 Apr;33(4):679-87. doi: 10.1067/mva.2001.112326.

  PMID: 11296317 BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Klas Österberg, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 9, 2013
• First Posted: February 20, 2013
• Study Start: November 1, 2011
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

SE (1)