Prime Time for Superficial Femoral Artery (SFA) - The SFA Study

NCT00902317 | Terminated

• 1 other identifier: 1115
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the different endovascular treatment modalities for the femoropopliteal segment, and to determine technical success, efficacy and patency at mid-term follow-up. Modalities include; Angioplasty/stent (Control group, Guidant), Cryoplasty/stent (Boston Scientific), Laser Angioplasty/stent (Spectranetics), SilverHawk Atherectomy/stent (Fox Hollow), and Viabahn Endograft (WL Gore).

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Determine if the devices (laser, atherectomy, polarcath, and viabahn endograft) offer better treatment, better outcome, and better patency than the angioplasty/stent treatment to the femoral artery.

  2 weeks, 3, 6, and 12 months

Study Arms (5)

Boston Scientific

ACTIVE COMPARATOR

The PolarCath peripheral balloon catheter (CryoVascular Systems, Inc., Los Gatos, CA) is a novel angioplasty system that simultaneously dilates and cools the plaque and vessel wall in the area of treatment. Cooling is achieved by inflating the balloon with nitrous oxide rather than the usual saline/contrast mixture.

Procedure: Cryoplasty (PolarCath peripheral balloon catheter)

Spectranetics

ACTIVE COMPARATOR

The excimer laser has unique properties that make it ideally suited to debulk atheromatous and thrombotic arterial blockages. LASER is an acronym for Light Amplification by Stimulated Emission of Radiation. However, there are many types of lasers, each distinguished by the wavelength of the emitted light, the effective power of the light beam, and whether the light is pulsed (like a flashbulb) or continuous (like a light bulb). The effectiveness of a given laser for intraarterial applications depends on how the light interacts with tissue inside an artery.

Procedure: Laser Angioplasty (Spectranetics)

Fox Hollow

ACTIVE COMPARATOR

The SilverHawk peripheral catheter system and cutter driver (FoxHollow Technologies, Redwood City, CA) are designed for the treatment of de novo and restenotic atherosclerotic lesions located in the native peripheral arteries. The catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the catheter is a small cutting assembly comprised of a rotating inner blade contained within a tubular housing. The proximal end of the catheter contains a connector and Positioning Lever designed to fit into a small, disposable, battery-driven Cutter Driver which powers the device.

Procedure: SilverHawk Atherectomy

WL Gore

ACTIVE COMPARATOR

Viabahn Endoprosthesis (W.L. Gore \& Associates, Flagstaff, AZ) is a flexible self-expanding endoluminal device consisting of expanded polytetrafluoroethylene (ePTFE) lining with an external Nitinol (NiTi=Nickel:Titanium) support extending along its entire length. The device is compressed and attached to a catheter delivery system. The Gore Viabahn Endoprosthesis is available in a wide range of diameters and lengths.

Device: Viabahn Endograft

Control Group, Guidant

PLACEBO COMPARATOR

Balloon angioplasty is a treatment that uses a catheter with a tiny balloon mounted on the end. The balloon is positioned through the narrowing/blockage in your leg artery, and then it is inflated to push the narrowing apart and restore a channel for blood flow. The balloon is then deflated and removed from your body. A Stent is a metal scaffold that is also delivered by a catheter and positioned through the narrowing in the artery. The stent is then expanded against the wall of the blood vessel to provide a wider channel for blood flow. The stent remains implanted in the blood vessel, and after a few weeks, the inner lining of the blood vessel will grow over the stent surface. The FDA has approved the use of certain stents for the treatment of narrowing in the leg arteries. Stents have been widely used in various parts of the body, including blocked blood vessels in the arms, legs, heart (coronary arteries), and kidneys (renal arteries).

Procedure: Angioplasty/Stent (Guidant "Absolute" stent)

Interventions

Cryoplasty (PolarCath peripheral balloon catheter) PROCEDURE

Cryoplasty involves advancing the balloon catheter to the site of the lesion and delivering liquid nitrous oxide into the balloon, where it expands into gas and inflates the balloon.

Boston Scientific

Laser Angioplasty (Spectranetics) PROCEDURE

The basic concept of laser angioplasty is to apply light energy directly to the arterial plaque, thereby altering the plaque in some helpful way, without damaging the surrounding artery.

Spectranetics

SilverHawk Atherectomy PROCEDURE

Once the catheter is connected to the cutter driver, by retracting the positioning lever this simultaneously turns on the motor and caused the distal portion of the cutter housing to deflect, forcing the device against the target lesion.

Fox Hollow

Viabahn Endograft DEVICE

The Gore-Viabahn should be positioned across the target lesion using the radiopaque hub and tip markers on the catheter. These markers identify the proximal and distal ends of the device, respectively.

WL Gore

Angioplasty/Stent (Guidant "Absolute" stent) PROCEDURE

A Stent is a metal scaffold that is also delivered by a catheter and positioned through the narrowing in the artery. The stent is then expanded against the wall of the blood vessel to provide a wider channel for blood flow. The stent remains implanted in the blood vessel, and after a few weeks, the inner lining of the blood vessel will grow over the stent surface.

Control Group, Guidant

Eligibility Criteria

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

You may qualify if:

• Stenosis \> 70% or total occlusion of the femoropopliteal segment that do not include the origin of the SFA.
• SFA and popliteal of \> 4 mm in diameter.
• TASC classification A, B, and C.
• At least one vessel run-off.

You may not qualify if:

• Age \< 18 years old.
• Medical condition that may cause the patient not to be compliant with follow-up (Ex. terminal cancer).
• Pregnancy
• Unwilling or unable to comply with the follow-up.
• Inability or refusal of informed consent.
• Systemic Infection (sepsis)
• Bleeding diathesis unable to use anticoagulation.
• Untreatable reaction to contrast material.
• SFA/Popliteal artery \< 4 mm diameter.
• Total occlusion of femoral artery with non-visualization of the origin of the SFA.
• Previous SFA/popliteal intervention (PTA, stenting etc.)
• Acute ischemia and/or acute thrombosis of the SFA-Popliteal segment.
• TASC type D.

Sponsors & Collaborators

• Arizona Heart Institute: lead

Study Sites (1)

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

Related Publications (9)

• McDaniel MD, Cronenwett JL. Basic data related to the natural history of intermittent claudication. Ann Vasc Surg. 1989 Jul;3(3):273-7. doi: 10.1016/S0890-5096(07)60040-5. No abstract available.

  PMID: 2673321 BACKGROUND

• Gray BH, Olin JW. Limitations of percutaneous transluminal angioplasty with stenting for femoropopliteal arterial occlusive disease. Semin Vasc Surg. 1997 Mar;10(1):8-16.

  PMID: 9068071 BACKGROUND

• Wilson SE, Wolf GL, Cross AP. Percutaneous transluminal angioplasty versus operation for peripheral arteriosclerosis. Report of a prospective randomized trial in a selected group of patients. J Vasc Surg. 1989 Jan;9(1):1-9.

  PMID: 2521362 BACKGROUND

• Ansel GM. Endovascular treatment of superficial femoral and popliteal arterial occlusive disease. J Invasive Cardiol. 2000 Jul;12(7):382-8. No abstract available.

  PMID: 10904449 BACKGROUND

• Henry M, Amor M, Ethevenot G, Henry I, Amicabile C, Beron R, Mentre B, Allaoui M, Touchot N. Palmaz stent placement in iliac and femoropopliteal arteries: primary and secondary patency in 310 patients with 2-4-year follow-up. Radiology. 1995 Oct;197(1):167-74. doi: 10.1148/radiology.197.1.7568818.

  PMID: 7568818 BACKGROUND

• Joyce, JD. An Overview of Cryoplasty. Endovasc Today 2004; vol 3, No. 9, 54-56

  BACKGROUND

• Ramaiah V, Cardenas J et al. Arizona Heart Hospital SilverHawk Experience. Endovasc Today Supplement Sept 2.004. pp. 11.

  BACKGROUND

• Rodriguez-Lopez JA, Soler L, Werner A, Martinez E, Papazoglou K, Diethrich EB. Long-term follow-up of endoluminal grafting for aneurysmal and occlusive disease in the superficial femoral artery. J Endovasc Surg. 1999 Aug;6(3):270-7. doi: 10.1583/1074-6218(1999)0062.0.CO;2.

  PMID: 10495156 BACKGROUND

• Rubin BG, Sicard GA. The Hemobahn endoprosthesis: a self-expanding polytetrafluoroethylene-covered endoprosthesis for the treatment of peripheral arterial occlusive disease after balloon angioplasty. J Vasc Surg. 2001 Feb;33(2 Suppl):S124-8. doi: 10.1067/mva.2001.111674.

  PMID: 11174823 BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Angioplasty; Angioplasty, Laser; Stents

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Laser Therapy; Ablation Techniques; Prostheses and Implants; Equipment and Supplies

Study Officials

• Julio Rodriguez-Lopez, M.D.

  Arizona Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 15, 2009
• Study Start: November 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 15, 2009

Record last verified: 2009-05

Locations

US (1)