Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00407940
Other study ID # 007A
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date December 2006
Est. completion date October 2007

Study information

Verified date June 2019
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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."


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Intervention

Device:
Lower extremity Atherectomy and Cryoplasty


Locations

Country Name City State
United States University of California, San Diego Medical Center, Hillcrest San Diego California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Zeller T, Rastan A, Schwarzwälder U, Frank U, Bürgelin K, Amantea P, Müller C, Flügel 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Ankle Brachial Index (ABI) improvement by =0.15 at 3, 6 and 12 months compared to baseline
Secondary Change in Walking Impairment Questionnaire (WIQ) functional status scores from baseline at 3, 6 and 12 months
Secondary Complications: defined as adverse events (AEs) or serious adverse events (SAEs). Complications may or may not be device related
Secondary Cost to patient and hospital: Including operating room times and duration of hospitalization.
See also
  Status Clinical Trial Phase
Recruiting NCT05400395 - Clinical Trial for GNX80 in Intermittent Claudication Phase 4
Active, not recruiting NCT02341716 - Hospital- and Home-based Supervised Exercise Versus UNsupervised Walk Advice For Patients With InTermittent Claudication N/A
Completed NCT02041169 - Lower Extremity Peripheral Arterial Disease and Exercise Ischemia N/A
Completed NCT00822172 - Evaluation of Cilostazol in Combination With L-Carnitine Phase 4
Recruiting NCT00538408 - Whole Body Magnetic Resonance Angiography in Ischemic Patients N/A
Completed NCT00618670 - Home-based vs. Supervised Exercise for People With Claudication N/A
Completed NCT00388128 - Caffeine and Intermittent Claudication Phase 3
Recruiting NCT00146666 - Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD) Phase 2
Completed NCT00134277 - Trial Comparing Different Medical Devices for Infragenual Dilatation N/A
Completed NCT01256775 - Effect of NCX4016 on Walking Distance in Patients With Peripheral Arterial Occlusive Disease (PAOD) Phase 2
Completed NCT00029991 - Extract of Ginkgo Biloba (EGB 761) and Vascular Function Phase 1/Phase 2
Recruiting NCT06299956 - Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark N/A
Not yet recruiting NCT05335161 - A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease Phase 1
Completed NCT04390282 - Secondary Prevention and Application-based Lifestyle Support for Patients With Intermittent Claudication N/A
Completed NCT03271710 - Study to Evaluate the Lower Extremity Intervention With Integrated Embolic Protection Using the Vanguard IEP System N/A
Completed NCT02380794 - Novel Treatment of Intermittent Claudication in Patients With Peripheral Arterial Disease Using Danshen Gegen (D&G) Capsule Phase 2
Active, not recruiting NCT02276937 - Randomized Phase IIb Trial of DVC1-0101 Phase 2
Completed NCT02097082 - Treatment of SFA Lesions With 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System N/A
Recruiting NCT00539266 - Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia Phase 2/Phase 3
Completed NCT00071266 - The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC Phase 3