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Prospective Evaluation of Safety and Efficacy Vertebral Drug-eluting Stent System (PESS)

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: NCT02328781
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Zhongrong Miao, Beijing Tiantan Hospital

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of Firehorus vertebral artery rapamycin-target-eluting stent system (hereinafter referred to as Firehorus) in treatment of symptomatic vertebral artery stenosis.

Condition or disease Intervention/treatment Phase
Vertebrobasilar Insufficiency Device: Drug-eluting stent Not Applicable

Detailed Description:
This clinical trial utilizes the prospective, multicenter, single-arm target value trial design, to evaluate the safety and efficacy of Firehorus vertebral artery rapamycin-target-eluting stent system (hereinafter referred to as Firehorus) in clinical use, for which 5 (or more) institutions will be selected as Clinical Trial Centre.Subjects will be screened in accordance with the inclusion and exclusion criteria of the this protocol and will be treated with Firehorus. Immediate stent implantation success rate of all subjects after surgery will be recorded, DSA angiographic follow-up will be performed at six months (±30 days) after surgery to assess the incidence of stent restenosis ( stenosis ≥ 50%) of the subjects, and the subjects will be followed up at 30 days (±7 days), 6 months (± 30 days), 12 months (± 30 days) after surgery , so as to evaluate the safety and efficacy of Firehorus in clinical use. The expected participating duration of each subject from enrollment to complete the follow-up is 12 months (± 30 days).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Multi-center Single-arm Target Value Clinical Trial for Evaluating Clinical Use Safety and Efficacy of the Firehorus Vertebral Artery Rapamycin-target-eluting Stent System
Actual Study Start Date : July 17, 2014
Actual Primary Completion Date : June 14, 2016
Actual Study Completion Date : November 25, 2016

Arm Intervention/treatment
Experimental: Experimental
Drug-eluting stent
Device: Drug-eluting stent



Primary Outcome Measures :
  1. rate of in-stent restenosis [ Time Frame: 6 months (± 30 days) after procedure ]
    DSA angiography performed after 6 months (± 30 days) showed the occurrence of in-stent restenosis and the restenosis rate ≥ 50%;


Secondary Outcome Measures :
  1. Immediate stent implantation success rate [ Time Frame: Immediate after the procedure ]
    postoperative angiography immediately after implantation of Firehorus indicated that residual stenosis ≤ 20% (the degree of stenosis is determined according to the WASID method)

  2. Any death or stroke related to the treated area [ Time Frame: 1 year ]
    Any death or stroke related to the treated area supplied by the target blood vessels during the follow-up period.

  3. Any death or stroke [ Time Frame: 1 year ]
    Any death or stroke during the follow-up period



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged over 18 years (including 18 years old), and under 80 years old (including 80 years old), male / Pregnancy Test ( -) female
  2. Patients with symptomatic vertebral artery stenosis not responding to drug therapy (defined as stroke or TIA occurred within 90 days, the patient is using at least one antithrombotic drug and receiving interventions for other vascular risk factors, such as antihypertensive therapy or lipid-lowering therapy for hypertensionor high cholesterol when stroke or TIA occurs)
  3. DSA angiography indicated target lesion stenosis ≥ 50% (the degree of stenosis is determined according to the WASID method)
  4. Length of vascular lesion ≤ 21mm
  5. Modified Rankin score < 3
  6. Suiform for placing with vertebral artery rapamycin-eluting stent, voluntary to receive follow-up and sing the informed consent

Exclusion Criteria:

  1. There is a series of stenosis lesion within the target lesion region
  2. TIA or non- disabling stroke (such as atrial fibrillation, etc.) caused by other factors other than vertebral artery stenosis
  3. The target lesion area had received previous surgery or endovascular treatment
  4. Combined with severe systemic disease or with other disease with the potential risk to cause fatal sudden illness, or the subject with life expectancy <2 years
  5. Unsuitable / intolerable to dual antiplatelet therapy
  6. Suffered from cerebral infarction and severe neurological dysfunction related to the responsible blood vessels (modified Rankin score ≥ 3 points)
  7. Experienced severe myocardial infarction within 2 weeks
  8. Accompanied by other intracranial lesions, such as intracranial hemorrhage, aneurysm, arteriovenous malformations, brain tumors, etc.
  9. Arterial dissection, moyamoya disease, arteritis active, unexplained non- atherosclerotic stenosis
  10. Serious target vessel tortuosity / calcification, leading to not suitable for stenting / lesion can not be expanded
  11. Severe renal impairment, or allergic to or resistant to contrast agent, rapamycin (Rapamycin) and its derivatives, cobalt based alloys, polylactic acid ;
  12. Patients participated in other drugs or equipment and have not reached the endpoint
  13. The patient or their family members do not agree to sign an informed consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328781


Locations
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China, Beijing
Beijing Tiantan Hospital
Beijing, Beijing, China, 100010
Sponsors and Collaborators
Zhongrong Miao
Investigators
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Study Chair: Zhongrong Miao, PhD,MD Beijing Tiantan Hospital
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Responsible Party: Zhongrong Miao, Chief of Interventional Neuroloy Department, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT02328781    
Obsolete Identifiers: NCT03859674
Other Study ID Numbers: BTH-PESS
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhongrong Miao, Beijing Tiantan Hospital:
vertebral artery stenosis
drug-eluting stent
Additional relevant MeSH terms:
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Vertebrobasilar Insufficiency
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases