Paclitaxel Eluting Stent in Long SFA Obstruction: A Prospective, Randomized Comparison With Bypass Surgery (finnptx)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Kuopio University Hospital
Sponsor:
Collaborators:
Helsinki University Central Hospital
Turku University Hospital
Tampere University Hospital
Oulu University Hospital
Finnish Society of Interventional radiology
North Karelia Central Hospital
Paijat-Hame Hospital District
Information provided by (Responsible Party):
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01450722
First received: October 7, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

Chronic lower limb ischemia due to atherosclerosis causes significant morbidity especially in elderly: the prevalence of asymptomatic obstructive peripheral atherosclerosis among 40-74 old is 4-22%. The prevalence of its milder symptomatic manifestation, intermittent claudication among 40 years old men is about 1% and among 70 years old it is 7%. In about 10% of the patients the ischemia worsens to threat the vitality of the limb. Although intermittent claudication has a benign prognosis and can often treated conservatively, more severe forms with extensive arterial obstructions require revascularization, either open surgical or endovascular. Surgical bypass operations are currently the standard reference for treating long femoral artery obstructions. Surgical bypass operations are accompanied by significant acute complications and late adverse effects, especially in patients with associated cardio-cerebrovascular and pulmonary diseases, and less invasive, safe, and effective endovascular therapies are seeked for. The long term patency rates of infrainguinal balloon angioplasty (PTA) vary largely in different studies but they are mostly poor when long femoral arterial obstructions have been treated. Drug eluting stents have shown great promise in coronary artery interventions. The purpose of this study is to compare Paclitaxel eluting Zilver PTX nitinol stent (Cook INC) with bypass surgery using PTFE graft to proximal popliteal artery in the treatment of long femoral artery obstructions (total length of 10-25 cm) in a prospective, randomized, Finnish multi center trial with consecutive claudicant and chronic critical ischemia patients. The aim is to randomize altogether 400 patients during about two years in five universities and in 2-3 central hospitals. The primary end point is patency at 24 month follow up. Secondary end points are primary success at patient discharge, complications, 30-day mortality, target lesion revascularization, quality of life, and economical analysis.


Condition Intervention Phase
Chronic Lower Limb Ischemia
Peripheral Athero Obstructive Disease
Critical Ischemia
Claudication
Procedure: bypass surgery, stent placement
Procedure: stent placement
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Paclitaxel Eluting Stent in Long Superficial Femoral Artery Obstruction: a Prospective, Randomized Comparison With Bypass Surgery Using PTFE Graft in a Finnish Multicenter Study

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • Primary patency of the stent or graft at two year follow up [ Time Frame: Ultrasound study at 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Amputation free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: October 2011
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: drug eluting stent
Paclitaxel eluting stent for long superficial femoral artery obstruction
Procedure: bypass surgery, stent placement
bypass surgery, stent placement
Other Name: PTX stent
Procedure: stent placement
placement of paclitaxel eluting stent in long superficial femoral artery obstruction
Other Name: PTX Cook
Active Comparator: bypass operation
femoropopliteal artery bypass operation by using synthetic PTFE graft
Procedure: bypass surgery, stent placement
bypass surgery, stent placement
Other Name: PTX stent

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suffering from severe life-style limiting claudication indicating revascularization as well as patients suffering from chronic critical ischemia and having de-novo SFA obstruction with total length of 7-20 cm will be recruited.
  • For claudicant patients an attempt of conservative treatment should be attempted before revacularization therapy. Both surgical bypass operation and endovascular treatment should be able to be safely performed;
  • the patient has not extensive additional cardio-pulmonary and/or cerebro-vascular diseases increasing remarkably operative risk.
  • At least one patent artery is to the ankle level.
  • The patient has given his/her informed consent.
  • Previous or simultaneus endovascular therapy of coexisting iliac disease is not a contraindication but study groups should be balanced.
  • Unplanned common femoral artery endarterectomy is not a contraindication when it is done at the same intervention to facilitate anastomosis creation.

Exclusion Criteria:

  • Patients who have not given their written informed consent.
  • Patient has allergy for iodine contrast agent.
  • Patient is undergoing hemodialysis.
  • Patient has undergone previous endovascular treatment for the target lesion (restenotic lesions).
  • Patient has also infrapopliteal disease indicating revascularization.
  • Patient is pregnant
  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: NCT01450722

Contacts
Contact: Hannu Manninen, professor 358-447113318 hannu.manninen@kuh.fi
Contact: Marja-Liisa Sutinen, nurse 358 44717 3941 marja-liisa.sutinen@kuh.fi

Locations
Finland
Kuopio University Hospital Recruiting
Kuopio, Finland
Contact: Pkks         
Contact: HUS         
Sponsors and Collaborators
Kuopio University Hospital
Helsinki University Central Hospital
Turku University Hospital
Tampere University Hospital
Oulu University Hospital
Finnish Society of Interventional radiology
North Karelia Central Hospital
Paijat-Hame Hospital District
Investigators
Principal Investigator: Hannu I Manninen, Professor Kuopio University Hospital
  More Information

No publications provided

Responsible Party: Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01450722     History of Changes
Other Study ID Numbers: KUH5063524
Study First Received: October 7, 2011
Last Updated: March 25, 2014
Health Authority: Finland: Ethics Committee

Keywords provided by Kuopio University Hospital:
Chronic lower limb ischemia
claudication
chronic critical ischemia

Additional relevant MeSH terms:
Ischemia
Pathologic Processes
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014