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

NCT01273350 | Unknown DMC

• 1 other identifier: Physician IDE G # 040160
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carotid Stenosis

Keywords

internal carotid artery; common carotid artery; bruit; tia

Outcome Measures

Primary Outcomes (1)

• Major adverse events, defined as death, ipsilateral stroke, myocardial infarction,(Q and non-Q wave) or major bleeding as 30 days post procedure

  30 days

Secondary Outcomes (1)

• Freedom from vascular complications ;Acute success defined by lesion, device, and procedural success; Freedom from any death, stroke MI (Q, non-Q wave), and from target lesion revascularization at one year

  1 Year

Study Arms (1)

Single arm

OTHER

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

Device: Carotid PTA and stenting

Interventions

Carotid PTA and stenting DEVICE

Percutaneous interventional treatment of carotid artery stenosis using XACT carotid artery stent and emboshield protection system with bivalirudin as the procedural anticoagulant

Single arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SPSI d.b.a Capital Cardiovascular Associates: lead

Study Sites (1)

Spirit Physycian Services Inc.d.b.a Capital Cardiovascular Associates

Camp Hill, Pennsylvania, 17011, United States

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis; Ischemic Attack, Transient

Interventions

Stents

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Rajesh M Dave, MD

  Spirit Physician Services Inc. d.b.a.Capital Cardiovascular Associates @ PinnacleHealth Hospitals; Holy Spirit Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajesh M Dave, MD

CONTACT

717-724-6450; rdintervention@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Executive Holy Spirit Cardiovascular Institute

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 10, 2011
• Study Start: October 1, 2004
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

US (1)