Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis

NCT ID: NCT02033135

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2017-08-31

Brief Summary

This randomized clinical study is intended to evaluate the use of Zilver PTX stents for treatment of thigh atherosclerosis.

Research question: Is there an adjuvant benefit of angioplasty and stenting using the new paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy alone in patients with stable, mild to moderate intermittent claudication caused by femoropopliteal lesions suitable for endovascular management.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Angioplasty with Zilver PTX

Angioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX) plus unsupervised exercise therapy, smoking cessation advice and best medical therapy.

Group Type: EXPERIMENTAL

Angioplasty with Zilver PTX

Intervention Type: PROCEDURE

Angioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX)

Best medical treatment

Intervention Type: OTHER

Treatment with antiplatelet and statins, smoking cessation advice and unsupervised walking exercise.

Zilver PTX

Intervention Type: DEVICE

Best medical treatment

Unsupervised exercise therapy, smoking cessation advice and best medical therapy.

Group Type: ACTIVE_COMPARATOR

Best medical treatment

Intervention Type: OTHER

Treatment with antiplatelet and statins, smoking cessation advice and unsupervised walking exercise.

Interventions

Angioplasty with Zilver PTX

Angioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX)

Intervention Type: PROCEDURE

Best medical treatment

Treatment with antiplatelet and statins, smoking cessation advice and unsupervised walking exercise.

Intervention Type: OTHER

Zilver PTX

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient has signed and dated the informed consent.
• Reference vessel (the above-the-knee femoropopliteal artery) diameter of 4 mm to 9 mm.
• Taget lesion(s) should be accessible for stenting, as imaged with angiography (digital subtraction, MRI or CTI), i.e. proximal cm of SFA must be open
• Patient has a de novo or restenotic lesion(s) with >50% stenosis documented angiographically and no prior stent in the target lesion.
• Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 (moderate claudication) or 3 (severe claudication) lasting for at least 3 months. (Positive Claudication Questionnaire)
• Exercise therapy, smoking cessation advise and best medical therapy must have been implemented at least 3 months ago and without significant clinical effect.
• Patient has a resting ABI <0.9 or an abnormal exercise ABI (decrease of more than 0.15) if resting ABI is normal. Patient with incompressible arteries (ABI >1.2) must have a TBI <0.8.
• Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 weeks, 6 months, 12 months, and at 24 months.

Exclusion Criteria

• Patient is pregnant, breast-feeding or under 18 years of age.
• Patient unable to understand and sign informed consent forms
• Patient is simultaneously participating in another investigational drug or device study.
• Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
• Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
• Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol.
• Patient 2-3 patent crural vessel runoff with <50% stenosis throughout its course.
• Activity limited by co-morbid condition other than claudication, for example: severe coronary artery disease; angina pectoris; chronic lung disease; neurological disorder such as hemiparesis; arthritis, or other musculoskeletal conditions including amputation and BMI > 40
• Other active significant medical problems such as cancer, known chronic renal disease (serum creatinine greater than 2.0 mg/dl within 60 days or renal replacement therapy), known chronic liver disease or anaemia, active substance abuse, or known history of dementia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Lise Pyndt Jørgensen

MD, Ph. D. student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Torben V Schroeder, MD, MDSc

Role: STUDY_DIRECTOR

Dept. of Vasc. Surg., Rigshospitalet, Blegdamsvej 9, 2100 KBH Ø, Denmark

Locations

Rigshospitalet

Copenhagen, Østerbro, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Lise P Jørgensen, MD,

Role: CONTACT

lpyndt@gmail.com

+45 3545 3654

Torben V Schroeder, MD, MDSc

Role: CONTACT

Facility Contacts

Lise Pyndt, MD

Role: primary

lpyndt@gmail.com

+45 35457458

Other Identifiers

H 4 2012 027

Identifier Type: -

Identifier Source: org_study_id