A Prospective, Non-Randomized, Evaluation of Low-Risk Patients Undergoing Carotid Stenting With ANgiomax (Bivalirudin)

SPSI d.b.a Capital Cardiovascular Associates

Status: Unknown

Conditions: Carotid Stenosis

Treatments: Device: Carotid PTA and stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT01273350

Physician IDE G # 040160

Details and patient eligibility

About

Prospective, non-randomized, single-center cohort study treating internal carotid artery stenosis using the Xact Carotid Artery Stent and emboshield distal protection system in conjunction with bivalirudin as the procedural anticoagulation

Full description

Primary objective is to evaluate the safety and feasibility of the XACT stent and emboshield with Angiomax as the procedural anticoagulant.

Primary safety endpoint is the occurrence of Major Adverse Events, defined as death, myocardial infarction (Q or non Q wave), and from target revascularization at one year

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patient (male or non-pregnant female)must be > than or= 18

• Qualifying non-invasive test (ultrasound or MRA) was performed less than 60 days prior to study entry. Carotid duplex study revealed:

  • Stenosis > or = to 50% in symptomatic patients
  • Stenosis > or = to 60% in asymptomatic patients

• Target lesion may be in the common or internal carotid artery and is amenable to treatment with angioplasty and stenting

• Patients taking warfarin may be included if their dosage is reduced before the procedure to result in an INR of 1.5 or less and a Prothrombin time of 15 seconds. Warfarin may be started after the procedure.

• Female patients of childbearing potential must have a documented negative pregnancy test during index hospitalization

• Patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local institutional review board or medical ethics committee

Exclusion Criteria: (Patients will be excluded from the study if ANY of the following conditions are present)

• There is total occlusion of the target carotid artery treatment site.
• The patient has an allergy or contraindication to aspirin, ticlopidine, clopidogrel, bivalirudin, nickel, titanium, or a sensitivity to contrast media, which cannot adequately pre-medicated.
• The subject has a platlet count< 100,000 cells/mm3 or 700,000 cells/mm3 or a WBC of < 3,000 cells/mm3.
• Stroke within 7 days prior to the procedure
• NIH stroke score > or = to 15 within 7 days prior to the procedure
• The patient has experienced a significant GI bleed within 6 months prior to study procedure
• The patient has active internal bleeding
• The patient has had major surgery or serious trauma within 6 weeks before enrollment
• The patient has excessive peripheral vascular disease that precludes safe sheath insertion
• The patient has had an intracranial hemorrhage, hemorrhagic stroke, major stroke or any stroke within one week of index procedure
• The patient has concurrent emboligenic cardiovascular disease not adequately treated with anticoagulant therapy
• The patient is on renal dialysis
• The patient has had low molecular weight heparin (LMWH) administered within 8 hours or less, prior to the procedure
• Severe hypertension not adequately controlled by antihypertensive therapy at the time of study entry(BP> 180/110mmHG)
• The patient is unable or unwilling to cooperate with the study follow-up procedures

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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154 participants in 1 patient group

Single arm

Other group

Description:

Single arm observational study looking at a "low risk" cohort of individuals with carotid stenosis

Treatment:

Device: Carotid PTA and stenting