Vertebrobasilar InsufficiencyPESSNCT02328781
Prospective Evaluation of Safety and Efficacy Vertebral Drug-eluting Stent System
A study testing Drug-eluting stent in people with Vertebrobasilar Insufficiency, run by Zhongrong Miao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vertebrobasilar Insufficiency
- What is being tested?
- Drug-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2014to 25 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18 years (including 18 years old), and under 80 years old (including 80 years old), male / Pregnancy Test ( -) female
- 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)
- DSA angiography indicated target lesion stenosis ≥ 50% (the degree of stenosis is determined according to the WASID method)
- Length of vascular lesion ≤ 21mm
- Modified Rankin score < 3
- Suiform for placing with vertebral artery rapamycin-eluting stent, voluntary to receive follow-up and sing the informed consent
Who cannot join
- There is a series of stenosis lesion within the target lesion region
- TIA or non- disabling stroke (such as atrial fibrillation, etc.) caused by other factors other than vertebral artery stenosis
- The target lesion area had received previous surgery or endovascular treatment
- 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
- Unsuitable / intolerable to dual antiplatelet therapy
- Suffered from cerebral infarction and severe neurological dysfunction related to the responsible blood vessels (modified Rankin score ≥ 3 points)
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- Experienced severe myocardial infarction within 2 weeks
- Accompanied by other intracranial lesions, such as intracranial hemorrhage, aneurysm, arteriovenous malformations, brain tumors, etc.
- Arterial dissection, moyamoya disease, arteritis active, unexplained non- atherosclerotic stenosis
- Serious target vessel tortuosity / calcification, leading to not suitable for stenting / lesion can not be expanded
- Severe renal impairment, or allergic to or resistant to contrast agent, rapamycin (Rapamycin) and its derivatives, cobalt based alloys, polylactic acid ;
- Patients participated in other drugs or equipment and have not reached the endpoint
- The patient or their family members do not agree to sign an informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Vertebrobasilar Insufficiency
- Being tested
- Drug-eluting stent
- Keywords
- vertebral artery stenosis, drug-eluting stent
- Medical subject headings
- Vertebrobasilar Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-eluting stentDevice
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Drug-eluting stent Receives: Device: Drug-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of in-stent restenosis
DSA angiography performed after 6 months (± 30 days) showed the occurrence of in-stent restenosis and the restenosis rate ≥ 50%;
Measured: 6 months (± 30 days) after procedure
Secondary outcomes (3)
Immediate stent implantation success rate
postoperative angiography immediately after implantation of Firehorus indicated that residual stenosis ≤ 20% (the degree of stenosis is determined according to the WASID method)
Measured: Immediate after the procedure
Any death or stroke related to the treated area
Any death or stroke related to the treated area supplied by the target blood vessels during the follow-up period.
Measured: 1 year
Any death or stroke
Any death or stroke during the follow-up period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study start17 Jul 2014
- Primary completion14 Jun 2016
- Study completion25 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebrobasilar InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongrong Miao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhongrong Miao, Beijing Tiantan Hospital
- Investigators
- Zhongrong Miao, PhD,MD, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328781
- Sponsor's protocol ID
- BTH-PESS
- Acronym
- PESS
- Status last verified
- Jun 2020
- First submitted
- 28 Dec 2014
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02328781
- Acronym / sponsor ID
- PESS / BTH-PESS
- Conditions
- Vertebrobasilar Insufficiency
- Keywords
- vertebral artery stenosis, drug-eluting stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Zhongrong MiaoUniversity, hospital or other
- Study start
- 17 Jul 2014 (actual)
- Primary completion
- 14 Jun 2016 (actual)
- Study completion
- 25 Nov 2016 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Drug-eluting stentDrug-eluting stent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged over 18 years (including 18 years old), and under 80 years old (including 80 years old), male / Pregnancy Test ( -) female
- 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)
- DSA angiography indicated target lesion stenosis ≥ 50% (the degree of stenosis is determined according to the WASID method)
- Length of vascular lesion ≤ 21mm
- Modified Rankin score < 3
Key exclusion criteria (13 listed)
- There is a series of stenosis lesion within the target lesion region
- TIA or non- disabling stroke (such as atrial fibrillation, etc.) caused by other factors other than vertebral artery stenosis
- The target lesion area had received previous surgery or endovascular treatment
- 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
- Unsuitable / intolerable to dual antiplatelet therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-eluting stent | Device | Experimental |
Primary outcome
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%;
3 secondary outcomes
Immediate stent implantation success rate
Time frame: Immediate after the procedure
Any death or stroke related to the treated area
Time frame: 1 year
Any death or stroke
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhongrong Miao, PhD,MD study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-eluting stent in people with Vertebrobasilar Insufficiency, run by Zhongrong Miao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of in-stent restenosis (time frame: 6 months (± 30 days) after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.