Peripheral Vascular DiseaseCLASENCT00902317
Prime Time for Superficial Femoral Artery (SFA) - The SFA Study
A study testing Cryoplasty (PolarCath peripheral balloon catheter), Laser Angioplasty (Spectranetics) and SilverHawk Atherectomy in people with Peripheral Vascular Disease, run by Arizona Heart Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Cryoplasty (PolarCath peripheral balloon catheter), Laser Angioplasty (Spectranetics) and SilverHawk Atherectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Medical Exclusion Criteria:
Show all 15Show fewer
- Systemic Infection (sepsis)
- Bleeding diathesis unable to use anticoagulation.
- Untreatable reaction to contrast material.
- Anatomical Endovascular Exclusion Criteria:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial for Femoropopliteal Arteries
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).
Read the detailed description
Peripheral vascular occlusive disease is a progressive and often debilitating form of atherosclerosis affecting the vessels of the upper and lower extremities. Patients typically present with complaints of pain in the involved extremity (claudication), others present with numbness, heaviness, or fatigue in the affected limb. With regards to the progression of the disease, up to 10% of patients with intermittent claudication may progress to limb loss over the course of 5 years. Past studies indicated that 2/3 of the patients' symptoms remained stable. Most recent studies, however, suggest that the natural history results in more disabling symptoms.
These patients can be evaluated with non-invasive studies including Ankle-Brachial Indices (ABI) or arterial duplex to assess the arterial flow. If stenosis or total occlusion is identified, an invasive study (angiogram) may be necessary. From these studies we are able to determine if the patient is a candidate for either a traditional surgical procedure (bypass) or a percutaneous treatment, similar to the angiogram.
The superficial femoral artery (SFA) has been the region most difficult to treat and maintain patency. Stenosis and/or occlusion often can occur by 6 months. Results of balloon angioplasty and stenting in the femoropopliteal segment have been for the most part variable and often with poor results. The SFA and popliteal arteries are extremely difficult to treat because the diffuse nature of disease, high degree of recoil, amplified reactivity, large number of occlusions, calcification, and the impact of inflow and run-off.
Angioplasty alone, is limited by a high frequency of dissection, significant recoil, and unacceptably high restenosis rates. While stenting has made an acute impact on dissection and recoil, restenosis rates have only modestly improved over time. More aggressive stent utilization has created other problems; in-stent restenosis, occlusion and stent-strut fracture.
Now, percutaneous revascularization has become an option for many patients due to a minimal invasive nature. Various other modalities have been used most recently to treat the femoropopliteal region, including the cool laser, atherectomy, cryoplasty and endoluminal grafts in an attempt to obtain a long-lasting result. At present, few studies compare the use of other devices different from stents in this anatomical location.
Randomization is done before the intervention by opening a sealed envelope containing the type of procedure. All procedures will be done under systemic heparinization using 3 to 5K ui of IV heparin. All cases will be approached percutaneously from the contralateral CFA to prevent that the access site interfere with patency outcome (i.e., antegrade approach). The use of stents as adjunctive Rx in laser, atherectomy, balloon angioplasty and cryoplasty cases will be a sole decision of the interventionist. PTA and stent will be the control group. To maintain uniformity, the stent to be used during the entire series will be the Guidant "Absolute" stent. The laser probe to be used in the study, is the 2.0, 2.2, or 2.5 mm (0.35 compatible) concentric catheter - Spectranetics. The endoluminal graft for the series is the Viabahn - W.L. Gore. The use of closure devices in the access site, will be decision of the interventionist. All patients should be treated post-op with Plavix 75 mg orally for three months starting the day of the intervention.
All subjects will be evaluated pre-procedure, 2 weeks, 3, 6, and 12 months. Subject follow-up at 2 weeks, 3, 6, and 12 months will include Bilateral ABIs, Arterial Duplex, and a Complete Physical Exam/Clinical Symptoms (presence of pulses).
- Conditions
- Peripheral Vascular Disease
- Being tested
- Cryoplasty (PolarCath peripheral balloon catheter), Laser Angioplasty (Spectranetics), SilverHawk Atherectomy, Viabahn Endograft, Angioplasty/Stent (Guidant "Absolute" stent)
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoplasty (PolarCath peripheral balloon catheter)Procedure or surgery
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.
Laser Angioplasty (Spectranetics)Procedure or surgery
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.
SilverHawk AtherectomyProcedure or surgery
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.
Viabahn EndograftDevice
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.
Angioplasty/Stent (Guidant "Absolute" stent)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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). Receives: Procedure: Angioplasty/Stent (Guidant "Absolute" stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startNov 2004
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona Heart Institute
- Sponsor type
- University, hospital or other
- Investigators
- Julio Rodriguez-Lopez, M.D., Principal investigator, Arizona Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902317
- Sponsor's protocol ID
- 1115
- Acronym
- CLASE
- Status last verified
- May 2009
- First submitted
- 14 May 2009
- Last updated
- 15 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 2673321Gray BH, Olin JW. Limitations of percutaneous transluminal angioplasty with stenting for femoropopliteal arterial occlusive disease. Semin Vasc Surg. 1997 Mar;10(1):8-16.
PubMed 9068071Wilson 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.
PubMed 2521362Ansel GM. Endovascular treatment of superficial femoral and popliteal arterial occlusive disease. J Invasive Cardiol. 2000 Jul;12(7):382-8. No abstract available.
PubMed 10904449Henry 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.
PubMed 7568818Joyce, JD. An Overview of Cryoplasty. Endovasc Today 2004; vol 3, No. 9, 54-56
Ramaiah V, Cardenas J et al. Arizona Heart Hospital SilverHawk Experience. Endovasc Today Supplement Sept 2.004. pp. 11.
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.
PubMed 10495156Rubin 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.
PubMed 11174823
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial for Femoropopliteal Arteries
- ClinicalTrials.gov ID
- NCT00902317
- Acronym / sponsor ID
- CLASE / 1115
- Conditions
- Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No funding
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Arizona Heart InstituteUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Peripheral vascular occlusive disease is a progressive and often debilitating form of atherosclerosis affecting the vessels of the upper and lower extremities. Patients typically present with complaints of pain in the involved extremity (claudication), others present with numbness, heaviness, or fatigue in the affected limb. With regards to the progression of the disease, up to 10% of patients with intermittent claudication may progress to limb loss over the course of 5 years. Past studies indicated that 2/3 of the patients' symptoms remained stable. Most recent studies, however, suggest that the natural history results in more disabling symptoms.
These patients can be evaluated with non-invasive studies including Ankle-Brachial Indices (ABI) or arterial duplex to assess the arterial flow. If stenosis or total occlusion is identified, an invasive study (angiogram) may be necessary. From these studies we are able to determine if the patient is a candidate for either a traditional surgical procedure (bypass) or a percutaneous treatment, similar to the angiogram.
The superficial femoral artery (SFA) has been the region most difficult to treat and maintain patency. Stenosis and/or occlusion often can occur by 6 months. Results of balloon angioplasty and stenting in the femoropopliteal segment have been for the most part variable and often with poor results. The SFA and popliteal arteries are extremely difficult to treat because the diffuse nature of disease, high degree of recoil, amplified reactivity, large number of occlusions, calcification, and the impact of inflow and run-off.
Angioplasty alone, is limited by a high frequency of dissection, significant recoil, and unacceptably high restenosis rates. While stenting has made an acute impact on dissection and recoil, restenosis rates have only modestly improved over time. More aggressive stent utilization has created other problems; in-stent restenosis, occlusion and stent-strut fracture.
Now, percutaneous revascularization has become an option for many patients due to a minimal invasive nature. Various other modalities have been used most recently to treat the femoropopliteal region, including the cool laser, atherectomy, cryoplasty and endoluminal grafts in an attempt to obtain a long-lasting result. At present, few studies compare the use of other devices different from stents in this anatomical location.
Randomization is done before the intervention by opening a sealed envelope containing the type of procedure. All procedures will be done under systemic heparinization using 3 to 5K ui of IV heparin. All cases will be approached percutaneously from the contralateral CFA to prevent that the access site interfere with patency outcome (i.e., antegrade approach). The use of stents as adjunctive Rx in laser, atherectomy, balloon angioplasty and cryoplasty cases will be a sole decision of the interventionist. PTA and stent will be the control group. To maintain uniformity, the stent to be used during the entire series will be the Guidant "Absolute" stent. The laser probe to be used in the study, is the 2.0, 2.2, or 2.5 mm (0.35 compatible) concentric catheter - Spectranetics. The endoluminal graft for the series is the Viabahn - W.L. Gore. The use of closure devices in the access site, will be decision of the interventionist. All patients should be treated post-op with Plavix 75 mg orally for three months starting the day of the intervention.
All subjects will be evaluated pre-procedure, 2 weeks, 3, 6, and 12 months. Subject follow-up at 2 weeks, 3, 6, and 12 months will include Bilateral ABIs, Arterial Duplex, and a Complete Physical Exam/Clinical Symptoms (presence of pulses).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Boston Scientific | Active comparator | Procedure: Cryoplasty (PolarCath peripheral balloon catheter)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. |
| Spectranetics | Active comparator | Procedure: Laser Angioplasty (Spectranetics)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. |
| Fox Hollow | Active comparator | Procedure: SilverHawk AtherectomyThe 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. |
| WL Gore | Active comparator | Device: Viabahn EndograftViabahn 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. |
| Control Group, Guidant | Placebo comparator | Procedure: Angioplasty/Stent (Guidant "Absolute" stent)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoplasty (PolarCath peripheral balloon catheter)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. | Procedure or surgery | Boston Scientific |
| Laser Angioplasty (Spectranetics)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. | Procedure or surgery | Spectranetics |
| SilverHawk AtherectomyOnce 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. | Procedure or surgery | Fox Hollow |
| Viabahn EndograftThe 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. | Device | WL Gore |
| Angioplasty/Stent (Guidant "Absolute" stent)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. | Procedure or surgery | Control Group, Guidant |
Primary outcome
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.
Time frame: 2 weeks, 3, 6, and 12 months
Results and safety
The study was stopped early (reason given: No funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2009.
- Background: PubMed 2673321McDaniel 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.
- Background: PubMed 9068071Gray BH, Olin JW. Limitations of percutaneous transluminal angioplasty with stenting for femoropopliteal arterial occlusive disease. Semin Vasc Surg. 1997 Mar;10(1):8-16.
- Background: PubMed 2521362Wilson 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.
- Background: PubMed 10904449Ansel GM. Endovascular treatment of superficial femoral and popliteal arterial occlusive disease. J Invasive Cardiol. 2000 Jul;12(7):382-8. No abstract available.
- Background: PubMed 7568818Henry 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.
- BackgroundJoyce, JD. An Overview of Cryoplasty. Endovasc Today 2004; vol 3, No. 9, 54-56
- BackgroundRamaiah V, Cardenas J et al. Arizona Heart Hospital SilverHawk Experience. Endovasc Today Supplement Sept 2.004. pp. 11.
- Background: PubMed 10495156Rodriguez-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.
- Background: PubMed 11174823Rubin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Rodriguez-Lopez, M.D. principal investigator
Arizona Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoplasty (PolarCath peripheral balloon catheter), Laser Angioplasty (Spectranetics) and SilverHawk Atherectomy in people with Peripheral Vascular Disease, run by Arizona Heart Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 weeks, 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00902317, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2009.