Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis

NCT02033135 | Unknown Phase 4

• 1 other identifier: H 4 2012 027
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Keywords

Atherosclerosis; Intermittent claudication; Angioplasty

Outcome Measures

Primary Outcomes (1)

• Maximal walking distance

  Walking distance will be quantified by standardized treadmill testing using constant speed of 3 km per hour with no incline for a maximum of 5 minutes.

  24 months

Secondary Outcomes (3)

• Ankle brachial pressure indices

  24 months

• Quality of life

  24 months

• Cost of the treatment

  24 months

Study Arms (2)

Angioplasty with Zilver PTX

EXPERIMENTAL

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

Procedure: Angioplasty with Zilver PTX; Other: Best medical treatment; Device: Zilver PTX

Best medical treatment

ACTIVE COMPARATOR

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

Other: Best medical treatment

Interventions

Angioplasty with Zilver PTX PROCEDURE

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

Angioplasty with Zilver PTX

Best medical treatment OTHER

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

Angioplasty with Zilver PTX; Best medical treatment

Zilver PTX DEVICE

Angioplasty with Zilver PTX

Eligibility Criteria

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

You may qualify if:

• Patient has signed and dated the informed consent.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Østerbro, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis; Intermittent Claudication

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Torben V Schroeder, MD, MDSc

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

  STUDY DIRECTOR

Central Study Contacts

Lise P Jørgensen, MD,

CONTACT

+45 3545 3654; lpyndt@gmail.com

Torben V Schroeder, MD, MDSc

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph. D. student

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 10, 2014
• Study Start: June 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2017
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

DK (1)