scholarly journals Open-Label Phase I Clinical Study to Assess the Safety and Efficacy of Cilostazol in Patients Undergoing Internal Carotid Artery Stent Placement

2016 ◽  
Vol 6 (1-2) ◽  
pp. 42-48
Author(s):  
Ameer E. Hassan ◽  
Haralabos Zacharatos ◽  
Mikayel Grigoryan ◽  
Wondwossen G. Tekle ◽  
Amir Khan ◽  
...  
Keyword(s):  
Carotid Artery ◽  
Internal Carotid Artery ◽  
Phase I ◽  
Stent Thrombosis ◽  
Stent Placement ◽  
Internal Carotid ◽  
Antiplatelet Drug ◽  
Open Label ◽  
End Point ◽  
Carotid Artery Stent

Background: One-month dual antiplatelet treatment, with aspirin and clopidogrel, following internal carotid artery stent placement is the current standard of care to prevent in-stent thrombosis. Cilostazol, an antiplatelet drug, has been demonstrated to have a safety profile comparable to aspirin and clopidogrel. Objective: To evaluate the safety and clinical efficacy of cilostazol and aspirin therapy following internal carotid artery stent placement up to 1 month postprocedure. Methods: A phase I open-label, nonrandomized two-center prospective study was conducted. All subjects received aspirin (325 mg/day) and cilostazol (200 mg/day) 3 days before extracranial stent placement. Two antiplatelet agents were continued for 1 month postprocedure followed by aspirin daily monotherapy. The primary efficacy end point was the 30-day composite occurrence of death, cerebral infarction, transient ischemic attack, and in-stent thrombosis. The primary safety end point was bleeding. Results: Twelve subjects (mean age ± SD, 66 ± 12 years; 9 males) were enrolled and underwent internal carotid artery angioplasty and stent placement. None of the subjects who successfully followed the study protocol experienced any complications at the 1- and 3-month follow-ups. One patient had a protocol deviation due to concurrent use of enoxaparin (1 mg/kg twice daily) in addition to aspirin and cilostazol, resulting in a fatal symptomatic intracerebral hemorrhage following successful stent placement on postprocedure day 1. One patient discontinued cilostazol after the first dose secondary to dizziness. Conclusion: The use of cilostazol and aspirin for internal carotid artery stent placement appears to be safe, but protocol compliance needs to be emphasized.

Open-label Phase I Clinical Study to Assess the Safety of Intravenous Eptifibatide in Patients Undergoing Internal Carotid Artery Angioplasty and Stent Placement

Neurosurgery ◽  
2001 ◽  
Vol 48 (5) ◽  
pp. 998-1005
Author(s):  
Adnan I. Qureshi ◽  
Zulfiqar Ali ◽  
M. Fareed K. Suri ◽  
Stanley H. Kim ◽  
Richard D. Fessler ◽  
...  
Keyword(s):  
Clinical Study ◽  
Carotid Artery ◽  
Internal Carotid Artery ◽  
Phase I ◽  
Stent Placement ◽  
Internal Carotid ◽  
Open Label ◽  
Open Label Phase

Abstract TP123: Open-label Phase I Clinical Study to Assess the Safety and Efficacy of Cilostazol in Patients Undergoing Carotid Artery Angioplasty and Stent Placement

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Ameer E Hassan ◽  
Haralabos Zacharatos ◽  
Mikayel Grigoryan ◽  
Saqib A Chaudhry ◽  
Wondwossen G Tekle ◽  
...  
Keyword(s):  
Phase I ◽  
Stent Placement ◽  
Internal Carotid ◽  
Antiplatelet Drug ◽  
Bleeding Complications ◽  
Carotid Angioplasty ◽  
Open Label ◽  
End Point ◽  
Symptomatic Intracerebral Hemorrhage ◽  
Cell Proliferation Inhibition

Background: One month dual antiplatelet therapy, with Aspirin and Clopidogrel, following intra- and/or extra-cranial stent placement is the standard of care to prevent in- stent thrombosis. Cilostazol, a novel antiplatelet drug, with vasodilatory effects and smooth muscle cell proliferation inhibition, has recently been demonstrated to be safe and efficacious in secondary stroke prevention and has a safety profile comparable to both Aspirin and Clopidogrel. Objective: To evaluate the safety and clinical efficacy of Cilostazol and Aspirin therapy following internal carotid angioplasty and stent placement prior to and one month post-procedure. Methods: We conducted a Phase I open label, non-randomized single center prospective study. All patients received Aspirin (325 mg/day) and Cilostazol (200 mg/day) for at least 3 days before internal carotid stenting. The two anti-platelet agents were continued for one month after the procedure and then patients were continued on aspirin daily. The primary efficacy end point was the 30-day composite occurrence of death, stroke, TIA, and unplanned endovascular revascularization. The primary safety end point was bleeding. Bleeding complications were classified as major (hemoglobin decrease >5 g/dl), minor (hemoglobin decrease 3-5 g/dl), or insignificant. Results: Twelve patients (mean age 66±12 years; 10 men) were enrolled and underwent internal carotid angioplasty and stent placement. One patient discontinued Cilostazol after the first dose, prior to stent placement, secondary to non-specific dizziness. Another patient did not follow study protocol and continued anticoagulation dose enoxoparin with Aspirin and Cilostazol resulting in symptomatic intracerebral hemorrhage 15 hours following successful stent placement; ultimately leading to withdrawal of care. None of the patients that successfully completed the study, and followed protocol, experienced any complications at 1-month and 3-month follow up. Conclusion: The use of Cilostazol and Aspirin for carotid angioplasty and stent placement appears to be safe but protocol compliance needs to be emphasized. Further studies are required to analyze the effectiveness and role of Cilostazol in neurointerventional procedures.

The Casper carotid artery stent: a unique all metal micromesh stent designed to prevent embolic release

2017 ◽  
Vol 10 (2) ◽  
pp. 133-136 ◽  
Author(s):  
Orlando Diaz ◽  
Gloria Lopez ◽  
John O F Roehm ◽  
Ginna De la Rosa ◽  
Fernando Orozco ◽  
...  
Keyword(s):  
Carotid Artery ◽  
Internal Carotid Artery ◽  
Stent Placement ◽  
Carotid Artery Stenosis ◽  
Internal Carotid ◽  
Cone Beam Ct ◽  
Large Cell ◽  
Internal Carotid Artery Stenosis ◽  
Artery Stenosis ◽  
Carotid Artery Stent

BackgroundStroke due to the release of embolic debris during the placement of a stent to correct carotid artery stenosis is a constant procedural and peri-procedural threat. The new all metal Casper stent has been created with two layers of nitinol, the inner layer of which has pores diminutive enough to prevent embolic release.ObjectiveTo evaluate the safety, effectiveness, and utility of the double layer nitinol Casper carotid artery stent in the treatment of patients with severe carotid artery stenosis.Methods19 patients with severe internal carotid artery stenosis, 14 symptomatic and 5 asymptomatic, were treated with the Casper stent. After stent placement, angiographic and cone beam CT images were recorded in all patients.ResultsThe unique low profile delivery system allowed for easy stent placement, re-sheathing, and repositioning of the stent. The large cell external layer produced excellent apposition to the artery wall. The inner layer prevented prolapse of atherosclerotic debris through the device. Plaque coverage was achieved; residual stenosis ranged from 0% to 20%. Long term angiographic follow-up in 5 patients showed wall apposition of the device covering the lesion and no restenosis. There were no procedure related complications. Two patients experienced a delayed ischemic stroke, likely related to inconsistent medical management.ConclusionsThe Casper has been an excellent stent for the treatment of internal carotid artery stenosis and its internal micromesh layer has been effective in preventing plaque prolapse. It provides the flexibility of large cell stents and the inner layer provides maximum protection against plaque prolapse.

Internal carotid artery stent placement without emboli protection: Results and long-term outcome

Neurology ◽  
2005 ◽  
Vol 65 (1) ◽  
pp. 132-134 ◽  
Author(s):  
D. Bibl ◽  
C. Lampl ◽  
I. Biberhofer ◽  
K. Kerschner ◽  
A. Kypta ◽  
...  
Keyword(s):  
Carotid Artery ◽  
Internal Carotid Artery ◽  
Stent Placement ◽  
Internal Carotid ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Carotid Artery Stent

scholarly journals Internal Carotid Artery Stent Placement: Our Standard Technique

2006 ◽  
Vol 34 (3) ◽  
pp. 190-193 ◽  
Author(s):  
Yasushi MATSUMOTO ◽  
Masayuki EZURA ◽  
Ryuji KONDOH ◽  
Naoto KIMURA ◽  
Akira TAKAHASHI
Keyword(s):  
Carotid Artery ◽  
Internal Carotid Artery ◽  
Stent Placement ◽  
Internal Carotid ◽  
Standard Technique ◽  
Carotid Artery Stent

scholarly journals Indications and Problems of Intracranial Stenting Report of Two Cases

2000 ◽  
Vol 6 (1_suppl) ◽  
pp. 149-154
Author(s):  
J. Deguchi ◽  
T. Kuroiwa ◽  
S. Nagasawa ◽  
G. Satoh ◽  
T. Ohta
Keyword(s):  
Carotid Artery ◽  
Internal Carotid Artery ◽  
External Force ◽  
Stent Placement ◽  
Internal Carotid ◽  
Total Occlusion ◽  
Intracranial Stenting ◽  
Linear Portion ◽  
Vertebrobasilar Artery ◽  
Intracranial Arteries

There have been few reports of stenting in the intracranial arteries. We used coronary stents in the chronically occluded intracranial vertebral artery and stenosis of internal carotid artery by the external force, and good blood flow were resumed. Stenosis in the intracranial arteries is also a good indication for stent placement when it is due to chronic total occlusion or artery compression by external force. But stent placement in the intracranial arteries has some problems. Stent placement in the intracranial artery is indicated only when the site of stent placement has a diameter of 3 mm or more, is a relatively linear portion of the vertebrobasilar artery or the internal carotid artery proximal to the C3 segment, and does not branch off perforating arteries or is already completely occluded.

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