Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery

Peripheral Vascular Diseases Clinical Trial

— Zilver PTX  

Official title:

Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120406
• Other study ID #: 06-026
• Secondary ID: PS2
• Status: Completed
• Phase: N/A
• First received: July 11, 2005
• Last updated: July 21, 2014
• Start date: March 2005
• Est. completion date: February 2014

Study information

• Verified date: July 2014
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be initiated upon approval by the Food and Drug Administration (FDA).

Description:

The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The above-the-knee femoropopliteal artery is defined as the superficial femoral artery (SFA) and the region of the popliteal artery above the plane of the femoral epicondyles. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be initiated upon approval by the FDA.

This study will include 480 patients who will receive the Zilver PTX stent or Percutaneous transluminal angioplasty (PTA) at up to 100 investigational sites. Clinical data will be captured on paper and electronic case report forms. Analyses will include evaluation of the composite event-free survival rate and the patency rate at 6- and 12-month follow-up. Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6. Patency will be assessed by duplex ultrasound in all patients. Patients may be randomized to one or more of the following sub-studies: IVUS and angiography at 6 months (stent patients only), angiography at 12 months, pharmacokinetic substudy (Zilver PTX patients only), or ultrasound (PTA patients only). The trial also includes provisions for patients experiencing PTA failure. These patients may be randomized to receive a Zilver PTX stent or a bare Zilver stent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. completion date: February 2014
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has signed and dated the informed consent.

• Patient has up to 2 documented stenotic or occluded atherosclerotic lesions (up ro 14 cm long) of the above-the-knee femoropopliteal artery, up to one in each limb, that meet all of the inclusion criteria and none of the exclusion criteria.

• 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 or greater.

• Patient has a resting Ankle Brachial Index (ABI) <0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with incompressible arteries (ABI >1.2) must have a Toe Brachial Index (TBI) <0.8.

• Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 months, 12 months, and at 2, 3, 4, and 5 years.

• Patient agrees to return for x-rays at 6 and 12 months.

• Patient agrees to return for angiography at 12 months.

• Patient agrees to be contacted by telephone at 1, 3, 9, and 18 months to assess clinical status.

Exclusion Criteria:

• Patient is pregnant or breast-feeding.

• Patient is simultaneously participating in another investigational drug or device study.

• Patient has significant stenosis or occlusion of inflow tract not successfully treated before this procedure.

• Patient has any planned surgical or interventional procedure within 30 days after the study procedure.

• Patient has had previous stenting of target vessel.

• 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 and, in the opinion of the investigator, cannot be adequately premedicated.

• Patient lacks at least one patent vessel of runoff with <50% stenosis throughout its course.

• Patient has untreated angiographically-evident thrombus in the target lesion.

[Additional criteria may apply.]

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Zilver® PTX™ Drug Eluting Vascular Stent
Stenting of the Superfemoropopliteal Artery

Procedure:
• Angioplasty
Angioplasty of the Superfemoropopliteal Artery

Locations

Country	Name	City	State
Germany	Herz-Zentrum	Bad Krozingen
Germany	Gemeinschaftspraxis	Leipzig
Germany	Heart Center Leipzig, Angiology	Leipzig
Germany	Universitatsklinikum Magdeburg	Magdeburg
Japan	Kokura Memorial Hospital	Kitakyushu-city	Fukuoka
Japan	Kyoto University Hospital	Kyoto
Japan	Nara Medical University	Nara-city
Japan	The Jikei University Hospital	Nishi-Shinbashi	Minato-ku
United States	Piedmont Hospital	Atlanta	Georgia
United States	JFK Memorial Center	Atlantis	Florida
United States	Bayview Medical Center	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	South Carolina Heart Center	Columbia	South Carolina
United States	MidWest Cardiology Research Foundation	Columbus	Ohio
United States	EMH Regional Medical Center	Elyria	Ohio
United States	Michigan Vascular Research Center	Flint	Michigan
United States	University of Florida	Gainesville	Florida
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	Pinnacle Health Harrisburg	Harrisburg	Pennsylvania
United States	Methodist Hospital	Houston	Texas
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	The Care Group	Indianapolis	Indiana
United States	Memorial -- Jacksonville	Jacksonville	Florida
United States	St. Luke's Hospital Kansas	Kansas City	Missouri
United States	Christus St. Patrick Hospital	Lake Charles	Louisiana
United States	Baptist Cardiac & Vascular Institute	Miami	Florida
United States	St. Luke's Hospital	Milwaukee	Wisconsin
United States	El Camino Hospital	Mountain View	California
United States	LDS	Murray	Utah
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Lenox Hill	New York	New York
United States	New York Presbyterian Hospital	New York	New York
United States	NYU Medical Center	New York	New York
United States	St. Luke's Roosevelt Hospital Center	New York	New York
United States	Tri-City Medical Center	Oceanside	California
United States	Orlando Regional Medical Center	Orlando	Florida
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	William Beaumont	Royal Oak	Michigan
United States	Peripheral Vascular Associates (PVA)	San Antonio	Texas
United States	Prairie Heart	Springfield	Illinois
United States	Stanford University Hospital and Clinics	Stanford	California
United States	University of Toledo University Medical Center	Toledo	Ohio
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Cook	Cook Japan Incorporated, MED Institute, Incorporated, William Cook Europe

Countries where clinical trial is conducted

United States,  Germany,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free Survival Rate	Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6.; Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and Event-free survival is based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.	12 months	Yes
Primary	Primary Patency	Primary patency is defined as a Peak systolic velocity (PSV) ratio < 2.0 or angiographic percent diameter stenosis < 50%.	12 months	No