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Endovascular Revascularization of Symptomatic Chronically Occluded Internal Carotid Artery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03176420
Recruitment Status : Withdrawn (Study is not funded)
First Posted : June 5, 2017
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
David Hasan, University of Iowa

Study Description
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Brief Summary:

Ischemic stroke is the fourth leading cause of disability and mortality in the United States. The overall risk of emboli detachment from a chronically occluded internal carotid artery (COICA) is around 7% per year. Despite receiving the best available medical therapy, about 6% to 24% of these patients will subsequently suffer transient or permanent ischemic complications annually. This has been theoretically attributed to a cerebrovascular hemodynamic impairment.

The management of chronic or subacute internal carotid artery (ICA) occlusions has been challenging clinically. Carotid endarterectomy and superficial temporal artery to middle cerebral artery bypass have been studied in high risk stroke patients with results showing no benefits in symptomatic COICA patients. Consequently, some centers have employed angioplasty and stenting for the management of these challenging lesions. The main concern with the endovascular treatment of COICA patients is the significant risk of perioperative complications such as distal embolization, vessel perforation, pseudoaneurysm formation, vessel dissection, fistula formation, and hyperperfusion syndrome. In this report, we propose for the first time a COICA classification, which could offer the interventionalist a guide of the technical feasibility and safety of endovascular recanalization of symptomatic COICA. We will assess the success of this classification in predicting endovascular recanalization of symptomatic COICA in a single -institution pilot study.


Condition or disease Intervention/treatment Phase
Stroke Occlusion Carotid Procedure: angioplasty and stenting of occluded cervical ICA Not Applicable

Detailed Description:

Classification of Carotid Artery Occlusion:

The radiographic imaging of 100 consecutive subjects with a diagnosis of chronically occluded cervical ICA (COICA) in the interval of 2009 - 2017 were evaluated at the University of Iowa Hospitals and Clinics were analyzed. Reviewers used morphology and location of occlusion, in addition to presence or absence of reconstitution of distal cervical ICA evident of MRA, CTA, and /or DSA to stratify this cohort of subjects into 4 categories. The rational for this classification was to evaluate whether it would potentially predict which COICA subjects could be viable candidates for the revascularization procedure using endovascular techniques. Of course this classification would need to be validated in larger cohort of patients.

Type A: The occlusion of the cervical ICA is tapered with proximal ICA lumen patent. In addition, the cavernous and/or petrous segment is reconstituted by either collaterals from the ECA and/or retrograde filling from the supraclinoid segment. This type is thought to be the most technically feasible to revascularize using endovascular techniques.

Type B: The occlusion of the cervical ICA is not tapered but there is a stump where the proximal portion of the cervical ICA lumen is patent. In addition, the cavernous and/or petrous segment is reconstituted by either collaterals from the ECA and/or retrograde filling from the supraclinoid segment. This type is thought to be the second best after type A to technically revascularize using endovascular techniques.

Type C: The occlusion of the cervical ICA is at the common carotid artery bifurcation (the cervical ICA appears completely amputated at the bifurcation), and there is no ICA lumen observed. The common carotid artery continues as ECA. However, the cavernous and/or petrous segment is reconstituted by either collaterals from the ECA and/or retrograde filling from the supraclinoid segment. This type is thought to be technically difficult to revascularize using endovascular techniques.

Type D: is the same as Type C except that there is no reconstitution of the cavernous and/or petrous segment. This type is thought to be the most difficult type to revascularize using endovascular techniques. This type should only considered for revascularization in acute ischemic stroke because this type could be encountered with tandem lesions during the acute phase.

To test whether our proposed classification could predict the technical feasibility and safety of endovascular revascularization of symptomatic COICA, we will perform a pilot study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Feasibility of Endovascular Revascularization of Chronically Occluded Cervical Internal Carotid Artery (COICA) Using Newly Suggested Radiographic Classification of COICA: Pilot Study
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arms and Interventions
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Arm Intervention/treatment
Experimental: Symptomayic chronically occluded cervical ICA Procedure: angioplasty and stenting of occluded cervical ICA
The procedure is performed under monitored anesthetic care. We will perform a thorough and complete six-vessel diagnostic angiogram to completely characterize the occlusion and presence of collaterals. A distal protection device is used unless technically can't be delivered beyond the occlusion or when the occlusion extends beyond the petrous segment of the internal carotid artery. Balloon angioplasty is performed followed by deployment of covered stents to jail the clot/organized thrombus. The carotid reconstruction is performed from the distal to the proximal segment with coronary stents that are telescoped until normal flow is encounter. The Blood pressure is managed rigorously during and after the procedure to minimize the chances of reperfusion hemorrhage.


Outcome Measures
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Primary Outcome Measures :
  1. brain hemorrhage [ Time Frame: 30 days post procedure ]
    will assess for any brain hemorrhage following the surgery


Secondary Outcome Measures :
  1. Transient ischemic stroke and stroke [ Time Frame: 3 months post procedure ]
  2. modified Rankin Score (mRS) [ Time Frame: 3 months post procedure ]
    assess and compare pre and post procedure mRS


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects are included if they have a COICA with ischemic symptoms refractory to medical therapy. Symptoms are evaluated based on the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria. Carotid occlusion is defined as 100% cross-sectional stenosis of the vessel lumen as documented on CT angiography or magnetic resonance angiography and confirmed with diagnostic angiogram (DSA).

Exclusion Criteria:

  • Asymptomatic patients with COICA.
  • 0-99% stenosis evident on DSA
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: David Hasan, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03176420    
Other Study ID Numbers: UIHC
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After 1 year following completion of the study, data finalization will occur, and the final dataset will be available for access and distribution. The final dataset will be stripped of identifiers prior to release for sharing.disclosure We will make the data and associated documentation available to users only under a data sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No