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

Carotid Stenosis Clinical Trial

Official title:

Physician I.D.E. G#040160; Low Risk Carotid Stenting Study Using Bivalirudin at PinnacleHealth Hospitals and Holy Spirit Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01273350
• Other study ID #: Physician IDE G # 040160
• Status: Recruiting
• Phase: N/A
• First received: January 7, 2011
• Last updated: July 30, 2014
• Start date: October 2004
• Est. completion date: December 2017

Study information

• Verified date: July 2014
• Source: SPSI d.b.a Capital Cardiovascular Associates
• Contact: Rajesh M Dave, MD
• Phone: 717-724-6450
• Email: rdintervention[@]yahoo.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

Device:
• Carotid PTA and stenting
Percutaneous interventional treatment of carotid artery stenosis using XACT carotid artery stent and emboshield protection system with bivalirudin as the procedural anticoagulant

Locations

Country	Name	City	State
United States	Spirit Physycian Services Inc.d.b.a Capital Cardiovascular Associates	Camp Hill	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
SPSI d.b.a Capital Cardiovascular Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes