ATHERO: Advanced Technology Halting Early Re-Stenosis and Occlusion

NCT00407940 | Withdrawn Phase 4

• 1 other identifier: 007A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Arterial Occlusive Disease; Intermittent Claudication

Keywords

Thrombosis; Claudication

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Lower extremity Atherectomy and Cryoplasty DEVICE

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego Medical Center, Hillcrest

San Diego, California, 92121, United States

Location

Related Publications (3)

• 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.

  PMID: 16105918 BACKGROUND

• Zeller 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.

  PMID: 15615558 BACKGROUND

• Muradin 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.

  PMID: 11568332 BACKGROUND

MeSH Terms

Conditions

Arterial Occlusive Diseases; Intermittent Claudication; Thrombosis

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Niren Angle, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2006
• First Posted: December 5, 2006
• Study Start: December 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: June 13, 2019

Record last verified: 2019-06

Locations

US (1)