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

NCT ID: NCT00120406

Last Updated: 2014-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2014-02-28

Brief 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).

Detailed 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.

Conditions

Peripheral Vascular Diseases

Study Design

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

Study Groups

1

Zilver® PTX™ Drug Eluting Vascular Stent

Group Type: EXPERIMENTAL

Zilver® PTX™ Drug Eluting Vascular Stent

Intervention Type: DEVICE

Stenting of the Superfemoropopliteal Artery

2

Angioplasty

Group Type: ACTIVE_COMPARATOR

Angioplasty

Intervention Type: PROCEDURE

Angioplasty of the Superfemoropopliteal Artery

Interventions

Zilver® PTX™ Drug Eluting Vascular Stent

Stenting of the Superfemoropopliteal Artery

Intervention Type: DEVICE

Angioplasty

Angioplasty of the Superfemoropopliteal Artery

Intervention Type: PROCEDURE

Other Intervention Names

Balloon; PTA

Eligibility Criteria

Inclusion Criteria

• Patient has signed and dated the informed consent.
• 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.]

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

Sponsors

William Cook Europe

INDUSTRY

Sponsor Role: collaborator

MED Institute, Incorporated

INDUSTRY

Sponsor Role: collaborator

Cook Japan Incorporated

INDUSTRY

Sponsor Role: collaborator

Cook Group Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Dake, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

El Camino Hospital

Mountain View, California, United States

Tri-City Medical Center

Oceanside, California, United States

Stanford University Hospital and Clinics

Stanford, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

JFK Memorial Center

Atlantis, Florida, United States

University of Florida

Gainesville, Florida, United States

Memorial -- Jacksonville

Jacksonville, Florida, United States

Baptist Cardiac & Vascular Institute

Miami, Florida, United States

Orlando Regional Medical Center

Orlando, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

OSF St. Francis Medical Center

Peoria, Illinois, United States

Prairie Heart

Springfield, Illinois, United States

St. Vincent Hospital

Indianapolis, Indiana, United States

The Care Group

Indianapolis, Indiana, United States

Christus St. Patrick Hospital

Lake Charles, Louisiana, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Bayview Medical Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Michigan Vascular Research Center

Flint, Michigan, United States

William Beaumont

Royal Oak, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

St. Luke's Hospital Kansas

Kansas City, Missouri, United States

NYU Medical Center

New York, New York, United States

St. Luke's Roosevelt Hospital Center

New York, New York, United States

New York Presbyterian Hospital

New York, New York, United States

Lenox Hill

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Good Samaritan Hospital

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

MidWest Cardiology Research Foundation

Columbus, Ohio, United States

EMH Regional Medical Center

Elyria, Ohio, United States

University of Toledo University Medical Center

Toledo, Ohio, United States

Pinnacle Health Harrisburg

Harrisburg, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

South Carolina Heart Center

Columbia, South Carolina, United States

Greenville Memorial Hospital

Greenville, South Carolina, United States

Methodist Hospital

Houston, Texas, United States

Peripheral Vascular Associates (PVA)

San Antonio, Texas, United States

LDS

Murray, Utah, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

St. Luke's Hospital

Milwaukee, Wisconsin, United States

Herz-Zentrum

Bad Krozingen, , Germany

Gemeinschaftspraxis

Leipzig, , Germany

Heart Center Leipzig, Angiology

Leipzig, , Germany

Universitatsklinikum Magdeburg

Magdeburg, , Germany

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

The Jikei University Hospital

Nishi-Shinbashi, Minato-ku, Japan

Kyoto University Hospital

Kyoto, , Japan

Nara Medical University

Nara, , Japan

Countries

United States; Germany; Japan

References

Dake MD, Fanelli F, Lottes AE, O'Leary EE, Reichert H, Jiang X, Fu W, Iida O, Zen K, Schermerhorn M, Zeller T, Ansel GM. Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent. Cardiovasc Intervent Radiol. 2021 Feb;44(2):196-206. doi: 10.1007/s00270-020-02648-6. Epub 2020 Oct 6.

Reference Type: DERIVED

PMID: 33025243 (View on PubMed)

Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Machan LS, Snyder SA, O'Leary EE, Ragheb AO, Zeller T; Zilver PTX Investigators. Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial. Circulation. 2016 Apr 12;133(15):1472-83; discussion 1483. doi: 10.1161/CIRCULATIONAHA.115.016900. Epub 2016 Mar 11.

Reference Type: DERIVED

PMID: 26969758 (View on PubMed)

Ohki T, Yokoi H, Kichikawa K, Kimura T, Snyder SA, Ragheb AO, O'Leary EE, Jaff MR, Ansel GM, Dake MD. Two-year analysis of the Japanese cohort from the Zilver PTX randomized controlled trial supports the validity of multinational clinical trials. J Endovasc Ther. 2014 Oct;21(5):644-53. doi: 10.1583/14-4753.1.

Reference Type: DERIVED

PMID: 25290792 (View on PubMed)

Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Snyder SA, O'Leary EE, Tepe G, Scheinert D, Zeller T; Zilver PTX Investigators. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol. 2013 Jun 18;61(24):2417-2427. doi: 10.1016/j.jacc.2013.03.034. Epub 2013 Apr 10.

Reference Type: DERIVED

PMID: 23583245 (View on PubMed)

Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011 Oct 1;4(5):495-504. doi: 10.1161/CIRCINTERVENTIONS.111.962324. Epub 2011 Sep 27.

Reference Type: DERIVED

PMID: 21953370 (View on PubMed)

Other Identifiers

PS2

Identifier Type: -

Identifier Source: secondary_id

06-026

Identifier Type: -

Identifier Source: org_study_id