Arterial Occlusive DiseasePhase 4NCT00407940
ATHERO: Advanced Technology Halting Early Re-Stenosis and Occlusion
A Phase 4 study testing Lower extremity Atherectomy and Cryoplasty in people with Arterial Occlusive Disease and Intermittent Claudication, run by University of California, San Diego at 1 site in United States.
Trial summary
The rise of minimal access surgery has heralded the approval of a number of endovascular devices with similar indications. This is particularly true for the treatment of lower extremity ischemia. Comparable devices are selected for patient use somewhat arbitrarily, often dependent on industry influence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Occlusive Disease, Intermittent Claudication
- What is being tested?
- Lower extremity Atherectomy and Cryoplasty
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Oct 2007
- Phase
- Phase 4
- 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
- The subject must give written informed consent and possess decision making capacity free of sedative or hypnotic agents.
- Age 18 years or older
- Candidate for angiography with intent-to-treat as determined by the Principle Investigator
- On angiography, ipsilateral to a symptomatic limb, a stenotic or occluded de novo or restenotic lesion in the common femoral artery, superficial femoral artery or above the knee popliteal artery measuring no longer than 10 cm (the upper limit of treatment in Cryoplasty pre-marketing)
- On angiography Lesion stenoses between 50% and 100% (inclusive)
- At least one runoff vessel
- Available for follow-up assessments
Who cannot join
- Contraindication to systemic anticoagulation e.g. history of documented hemorrhage requiring treatment within the past 30 days; history of a hereditary bleeding disorder or known bleeding diathesis; major surgery or trauma, open chest massage, ocular surgery or hemorrhagic retinopathy within the past 30 days; puncture at a non-compressible site within 48 hours prior to planned procedure; history of stroke, intracranial hemorrhage, or central nervous system structural abnormalities within the past 3 months
- History of endovascular surgery procedure or open vascular surgery on the index limb within the last 30 days
- History of significant acute or chronic kidney disease that would preclude contrast angiography
- Known allergy to contrast agents
- History of heparin-induced thrombocytopenia (HIT)
- Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to randomization
Show all 12Show fewer
- Any thrombolytic therapy within 30 days of randomization
- Pregnancy, lactation, or possession of any child bearing potential without evidence of surgical infertility or passage of 12 months since the last day of the subject's last menstrual period.
- Target lesion involving a dacron prosthesis or a prosthetic of unknown material
- Target lesion extending into the orifice of the profunda femoris artery
- Prisoner status
- Any other subject feature that in the opinion of the investigator should preclude study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego Medical Center, Hillcrest
San Diego, California, 92121
About this study
Official title: ATHERO: Advanced Technology Halting Early Re-Stenosis and Occlusion. A Prospective Randomized Trial Comparing Silverhawk™ Atherectomy to CryoPlasty® Therapy for Lower Extremity Claudication
The rise of minimal access surgery has heralded the approval of a number of endovascular devices with similar indications. This is particularly true for the treatment of lower extremity ischemia. Comparable devices are selected for patient use somewhat arbitrarily, often dependent on industry influence. An unmet need is NON-industry sponsored prospective trials COMPARING devices head-to-head so that endovascular surgeons can even contemplate evidence-based device selection. At present, we seek to compare two new high-technology devices that are indicated to treat lower extremity arterial stenoses associated with claudication.
Read the detailed description
Peripheral arterial disease affects more than 12 million Americans, and its incidence is growing annually. The male/female ratio of patients with claudication is just under 2/1. The arteries involved by atherosclerosis involve the arteries to the thigh and leg. These include the femoral and popliteal arteries. Fifty percent of people with femoral-popliteal PVD are symptomatic. Symptoms are typically related to exertional fatigue of thigh and calf muscles. These symptoms, referred to as claudication, seldom represent a life or even limb-threatening process. They do, however, result in significantly decreased productivity and an often devastating quality of life.
Traditional interventions for lower extremity claudication include technologies invented in the first half of the 20th century including surgical bypass; and those invented in the second half of the twentieth century, including balloon angioplasty and stenting. These interventions have substantial shortcomings. It is, however, relevant to note that endovascular (aka endoluminal or endovascular surgery) is becoming increasingly popular and gaining wide-spread support from vascular interventionalist societies wordwide.
The main shortcomings of angioplasty and stenting is the resultant inflammatory response. The mechanical injury to blood vessels is followed by a complex repair response comprising intimal vascular smooth muscle cell (VSMC) hyperplasia, vessel wall scarring and shrinkage of the vascular lumen, often resulting in reduced blood flow and subsequent muscle (or end organ) ischemia. Rodent, rabbit and large animal models have provided valuable insights into the pathophysiology of these responses.
The devices utilized in this protocol are both FDA approved for the procedures described in the protocol. The devices include the Silverhawk™ System (FoxHollow Technologies, Redwood City, CA) and the PolarCath™ Peripheral Dilatation System, Boston Scientific, Natick, Massachusetts). Hereafter both products will be referred to as the "Devices."
- Being tested
- Lower extremity Atherectomy and Cryoplasty
- Keywords
- Thrombosis, Claudication
- Medical subject headings
- Arterial Occlusive Diseases, Intermittent Claudication, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower extremity Atherectomy and CryoplastyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary target patency at 12 months. The "target" is the index stenotic lesion(s). Primary patency is defined as <50% residual stenosis by duplex (color-flow Doppler) scan analysis, with antegrade flow to the target vessel.
Secondary outcomes (4)
Ankle Brachial Index (ABI) improvement by ≥0.15 at 3, 6 and 12 months compared to baseline
Change in Walking Impairment Questionnaire (WIQ) functional status scores from baseline at 3, 6 and 12 months
Complications: defined as adverse events (AEs) or serious adverse events (SAEs). Complications may or may not be device related
Cost to patient and hospital: Including operating room times and duration of hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niren Angle, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407940
- Sponsor's protocol ID
- 007A
- Status last verified
- Jun 2019
- First submitted
- 4 Dec 2006
- Last updated
- 13 Jun 2019
- Results posted
- No
Publications
Laird J, Jaff MR, Biamino G, McNamara T, Scheinert D, Zetterlund P, Moen E, Joye JD. Cryoplasty for the treatment of femoropopliteal arterial disease: results of a prospective, multicenter registry. J Vasc Interv Radiol. 2005 Aug;16(8):1067-73. doi: 10.1097/01.RVI.0000167866.86201.4E.
PubMed 16105918Zeller T, Rastan A, Schwarzwalder U, Frank U, Burgelin K, Amantea P, Muller C, Flugel PC, Neumann FJ. Percutaneous peripheral atherectomy of femoropopliteal stenoses using a new-generation device: six-month results from a single-center experience. J Endovasc Ther. 2004 Dec;11(6):676-85. doi: 10.1583/04-1316R.1.
PubMed 15615558Muradin GS, Bosch JL, Stijnen T, Hunink MG. Balloon dilation and stent implantation for treatment of femoropopliteal arterial disease: meta-analysis. Radiology. 2001 Oct;221(1):137-45. doi: 10.1148/radiol.2211010039.
PubMed 11568332
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATHERO: Advanced Technology Halting Early Re-Stenosis and Occlusion. A Prospective Randomized Trial Comparing Silverhawk™ Atherectomy to CryoPlasty® Therapy for Lower Extremity Claudication
- ClinicalTrials.gov ID
- NCT00407940
- Acronym / sponsor ID
- 007A
- Keywords
- Thrombosis, Claudication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 5 Dec 2006 (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 rise of minimal access surgery has heralded the approval of a number of endovascular devices with similar indications. This is particularly true for the treatment of lower extremity ischemia. Comparable devices are selected for patient use somewhat arbitrarily, often dependent on industry influence. An unmet need is NON-industry sponsored prospective trials COMPARING devices head-to-head so that endovascular surgeons can even contemplate evidence-based device selection. At present, we seek to compare two new high-technology devices that are indicated to treat lower extremity arterial stenoses associated with claudication.
Detailed description
Peripheral arterial disease affects more than 12 million Americans, and its incidence is growing annually. The male/female ratio of patients with claudication is just under 2/1. The arteries involved by atherosclerosis involve the arteries to the thigh and leg. These include the femoral and popliteal arteries. Fifty percent of people with femoral-popliteal PVD are symptomatic. Symptoms are typically related to exertional fatigue of thigh and calf muscles. These symptoms, referred to as claudication, seldom represent a life or even limb-threatening process. They do, however, result in significantly decreased productivity and an often devastating quality of life.
Traditional interventions for lower extremity claudication include technologies invented in the first half of the 20th century including surgical bypass; and those invented in the second half of the twentieth century, including balloon angioplasty and stenting. These interventions have substantial shortcomings. It is, however, relevant to note that endovascular (aka endoluminal or endovascular surgery) is becoming increasingly popular and gaining wide-spread support from vascular interventionalist societies wordwide.
The main shortcomings of angioplasty and stenting is the resultant inflammatory response. The mechanical injury to blood vessels is followed by a complex repair response comprising intimal vascular smooth muscle cell (VSMC) hyperplasia, vessel wall scarring and shrinkage of the vascular lumen, often resulting in reduced blood flow and subsequent muscle (or end organ) ischemia. Rodent, rabbit and large animal models have provided valuable insights into the pathophysiology of these responses.
The devices utilized in this protocol are both FDA approved for the procedures described in the protocol. The devices include the Silverhawk™ System (FoxHollow Technologies, Redwood City, CA) and the PolarCath™ Peripheral Dilatation System, Boston Scientific, Natick, Massachusetts). Hereafter both products will be referred to as the "Devices."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject must give written informed consent and possess decision making capacity free of sedative or hypnotic agents.
- Age 18 years or older
- Candidate for angiography with intent-to-treat as determined by the Principle Investigator
- On angiography, ipsilateral to a symptomatic limb, a stenotic or occluded de novo or restenotic lesion in the common femoral artery, superficial femoral artery or above the knee popliteal artery measuring no longer than 10 cm (the upper limit of treatment in Cryoplasty pre-marketing)
- On angiography Lesion stenoses between 50% and 100% (inclusive)
Key exclusion criteria (12 listed)
- Contraindication to systemic anticoagulation e.g. history of documented hemorrhage requiring treatment within the past 30 days; history of a hereditary bleeding disorder or known bleeding diathesis; major surgery or trauma, open chest massage, ocular surgery or hemorrhagic retinopathy within the past 30 days; puncture at a non-compressible site within 48 hours prior to planned procedure; history of stroke, intracranial hemorrhage, or central nervous system structural abnormalities within the past 3 months
- History of endovascular surgery procedure or open vascular surgery on the index limb within the last 30 days
- History of significant acute or chronic kidney disease that would preclude contrast angiography
- Known allergy to contrast agents
- History of heparin-induced thrombocytopenia (HIT)
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 |
|---|---|---|
| Lower extremity Atherectomy and Cryoplasty | Device | – |
Primary outcome
Primary target patency at 12 months. The "target" is the index stenotic lesion(s). Primary patency is defined as <50% residual stenosis by duplex (color-flow Doppler) scan analysis, with antegrade flow to the target vessel.
4 secondary outcomes
Ankle Brachial Index (ABI) improvement by ≥0.15 at 3, 6 and 12 months compared to baseline
Change in Walking Impairment Questionnaire (WIQ) functional status scores from baseline at 3, 6 and 12 months
Complications: defined as adverse events (AEs) or serious adverse events (SAEs). Complications may or may not be device related
Cost to patient and hospital: Including operating room times and duration of hospitalization.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Background: PubMed 16105918Laird J, Jaff MR, Biamino G, McNamara T, Scheinert D, Zetterlund P, Moen E, Joye JD. Cryoplasty for the treatment of femoropopliteal arterial disease: results of a prospective, multicenter registry. J Vasc Interv Radiol. 2005 Aug;16(8):1067-73. doi: 10.1097/01.RVI.0000167866.86201.4E.
- Background: PubMed 15615558Zeller T, Rastan A, Schwarzwalder U, Frank U, Burgelin K, Amantea P, Muller C, Flugel PC, Neumann FJ. Percutaneous peripheral atherectomy of femoropopliteal stenoses using a new-generation device: six-month results from a single-center experience. J Endovasc Ther. 2004 Dec;11(6):676-85. doi: 10.1583/04-1316R.1.
- Background: PubMed 11568332Muradin GS, Bosch JL, Stijnen T, Hunink MG. Balloon dilation and stent implantation for treatment of femoropopliteal arterial disease: meta-analysis. Radiology. 2001 Oct;221(1):137-45. doi: 10.1148/radiol.2211010039.
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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.
Niren Angle, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lower extremity Atherectomy and Cryoplasty in people with Arterial Occlusive Disease and Intermittent Claudication, run by University of California, San Diego 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 7 inclusion and 12 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: withdrawn, as of the sponsor's last update on 13 Jun 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Primary target patency at 12 months. The "target" is the index stenotic lesion(s). Primary patency is defined as <50% residual stenosis by duplex (color-flow Doppler) scan analysis, with antegrade flow to the target vessel.. 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 NCT00407940, which also lists 3 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 13 Jun 2019.