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

NCT01450722 | Recruiting Phase 3 DMC

• 1 other identifier: KUH5063524
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Lower Limb Ischemia; Peripheral Athero Obstructive Disease; Critical Ischemia; Claudication

Keywords

Chronic lower limb ischemia; claudication; chronic critical ischemia

Outcome Measures

Primary Outcomes (1)

• Primary patency of the stent or graft at two year follow up

  Ultrasound study at 2 years

Secondary Outcomes (1)

• Amputation free survival

  2 years

Study Arms (2)

drug eluting stent

ACTIVE COMPARATOR

Paclitaxel eluting stent for long superficial femoral artery obstruction

Procedure: bypass surgery, stent placement; Procedure: stent placement

bypass operation

ACTIVE COMPARATOR

femoropopliteal artery bypass operation by using synthetic PTFE graft

Procedure: bypass surgery, stent placement

Interventions

bypass surgery, stent placement PROCEDURE

bypass surgery, stent placement

Also known as: PTX stent

bypass operation; drug eluting stent

stent placement PROCEDURE

placement of paclitaxel eluting stent in long superficial femoral artery obstruction

Also known as: PTX Cook

drug eluting stent

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuopio University Hospital: lead
• Helsinki University Central Hospital: collaborator
• Turku University Hospital: collaborator
• Tampere University Hospital: collaborator
• Oulu University Hospital: collaborator
• Finnish Society of Interventional radiology: collaborator
• North Karelia Central Hospital: collaborator
• Paijat-Hame Hospital District: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, Finland

RECRUITING

Related Publications (1)

• Bjorkman P, Auvinen T, Hakovirta H, Romsi P, Turtiainen J, Manninen H, Venermo M. Drug-Eluting Stent Shows Similar Patency Results as Prosthetic Bypass in Patients with Femoropopliteal Occlusion in a Randomized Trial. Ann Vasc Surg. 2018 Nov;53:165-170. doi: 10.1016/j.avsg.2018.04.014. Epub 2018 Jun 7.

  PMID: 29886215 DERIVED

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hannu I Manninen, Professor

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannu Manninen, professor

CONTACT

358-447113318; hannu.manninen@kuh.fi

Marja-Liisa Sutinen, nurse

CONTACT

358 44717 3941; marja-liisa.sutinen@kuh.fi

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 12, 2011
• Study Start: October 1, 2011
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

FI (1)