Firehorus Rapamycin Target Eluting Vertebral Artery Stent System in Clinical Application

Drug Eluting Stent Clinical Trial

Official title:

A Prospective, Multicenter, Single-Arm, Objective Performance Criteria-Clinical Study: Evaluation for Safety and Efficacy of Firehorus Rapamycin Target Eluting Vertebral Artery Stent System in Clinical Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03859674
• Other study ID #: FirehorusP-2014-03
• Status: Completed
• Phase: N/A
• Start date: July 17, 2014
• Est. completion date: November 25, 2016

Study information

• Verified date: February 2019
• Source: MicroPort NeuroTech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial uses a prospective, multicenter, single-arm, objective performance criteria-design, aiming to evaluate the safety and effectiveness of Firehorus Rapamycin Target Eluting Vertebral Artery Stent System .

Description:

This clinical trial uses a prospective, multicenter, single-arm, objective performance criteria-design, aiming to evaluate the safety and effectiveness of Firehorus Rapamycin Target Eluting Vertebral Artery Stent System (hereinafter referred to as Firehorus) in clinical application, in which 6 clinical trial centers are selected to employ Firehorus to treat subjects who are screened according to inclusion and exclusion criteria defined in this protocol. During this clinical trial, postoperative immediate success rate of stent implantation is recorded after surgery; DSA angiographic follow up is performed at 6 months (±30 days) after surgery; in-stent restenosis rate (stenosis degree ≥50%) is evaluated; and clinical follow up is performed at 30 days (±7d), 6 months (±30d), 12 months (±30d) after surgery; in order to evaluate the safety and effectiveness of Firehorus in clinical application. Each subject is expected to participate in the trial for 12 months (±30d) from entering the group to completion of follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 25, 2016
• Est. primary completion date: June 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Aged 18 years or above (including 18 years old), 80 years old below (including 80 years old), male or women with pregnancy test (-);

2. Symptomatic vertebral artery stenosis patients who have failed in medical treatment (defined as patients who have suffered from stroke or TIA within 90 days, and are taking at least one antithrombotic drugs as well as interventions in other vascular risks, such as hypertension and hyperlipidemia decompression or lipid reducing);

3. DSA angiography showed target lesion stenosis degree =50% (Stenosis degrees are determined according to WASID method);

4. Diseased vessel length = 21mm;

5. Modified Rankin score <3;

6. Patients who are suitable for implantation of rapamycin target eluting vertebral artery stent and are voluntary to be followed up and sign the informed consent form.

Exclusion Criteria:

1. There are tandem stenosis in the target lesion area;

2. TIA or non-disabling stroke (such as atrial fibrillation) caused by factors other than vertebral artery stenosis;

3. Surgical treatment or endovascular intervention have been previously performed in the target lesion area;

4. Concurrent severe systemic diseases or other diseases with potential sudden death risks, or life expectancy of subjects <2 years;

5. Unsuitable/intolerable to dual antiplatelet therapy;

6. Patients who have suffered from cerebral infarction and have left over severe neurological dysfunctions related to offending vessels (modified Rankin score =3);

7. Patients who have had severe myocardial infarction within 2 weeks;

8. Accompanied with other intracranial diseases, such as intracranial hemorrhage, aneurism, arteriovenous malformations, intracranial tumors;

9. Non atherosclerotic stenosis of arterial dissection, moyamoya, active phase of arteritis, and other unknown causes;

10. Target vessels can not be implanted stents/lesions cannot be dilated due to severe tortuosity/calcification;

11. Patients with severe renal dysfunction, or allergic or resistant to contrast media, rapamycin and its derivatives, cobalt-base alloy, polylactic acid;

12. Patients who have participated in other drug or device studies but not reached endpoints;

13. Patients or families do not agree to sign informed consent form.

Related Conditions & MeSH terms

• Drug Eluting Stent
• Vertebral Artery Stenosis
• Vertebrobasilar Insufficiency

Intervention

Device:
• Firehorus
Using Firehorus to treat patients who have Symptomatic vertebral artery stenosis, according to the inclusion and exclusion criteria defined in the protocol.

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
MicroPort NeuroTech Co., Ltd.	Beijing Tiantan Hospital, China National Center for Cardiovascular Diseases, Qilu Hospital of Shandong University, RenJi Hospital, Southwest Hospital, China, Tang-Du Hospital, Xinqiao Hospital of Chongqing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent restenosis	Number of participants with in-stent restenosis with stenosis degree=50%(stenosis degree is determined according to WASID method)	6 months after stent implantation
Secondary	Successful stent implantation	Number of participants with successful stent implantation with residual stenosis degree<20% (stenosis degree is determined according to WASID method)	Immediately after stent implantation
Secondary	Any death or stroke	Number of participants with death or stroke	1 year after stent implantation
Secondary	Any death or stroke related to treatments for target vessel blood supply area	Number of participants with death or stroke related to treatments for target vessel blood supply area	1 year after stent implantation