Implantation of CERENOVUS ENTERPRISE 2 Intracranial Stent in Patients With Severe Symptomatic Intracranial Atherosclerotic Stenosis: A Multicenter, Prospective and Single-Arm Study in China

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to evaluate the safety and effectiveness of CERENOVUS ENTERPRISE 2 intracranial stent implantation in treatment of participants with severe symptomatic intracranial atherosclerotic stenosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ Pre-procedure inclusion criteria

• Participants aged 22-80 years old

• All participants are required to meet at least one additional criteria (a-f) provided below to qualify for the study; (a) insulin dependent diabetes for at least 15 years; (b) at least 2 of the following atherosclerotic risk factors: hypertension (blood pressure \[BP\] greater than or equal to \[\>=\] 140/90 or on antihypertensive therapy); dyslipidemia (low density lipoprotein \[LDL\] 130 milligrams per deciliter \[mg/dl\] or high density lipoprotein \[HDL\] less than \[\<\] 40 mg/dl or fasting triglycerides \>= 150 mg/dl or on lipid lowering therapy); smoking; abnormal glucose metabolism (fasting blood glucose \>= 6.2 millimole per liter (mmol/L) or 2 hours postprandial blood glucose \>= 7.8mmol/L); family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was \<55 years of age for men or \<65 for women at the time of the event ; (c) history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease ; (d) any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic ; (e) Aortic arch atheroma or atherosclerotic aortic aneurysm documented by non-invasive vascular imaging or catheter angiography ; (f) High resolution magnetic resonance imaging (MRI) imaging confirmed the presence of atherosclerotic plaques in the target arterial stenosis

• Participants with symptomatic intracranial atherosclerotic stenosis who is receiving medical treatment (that is, receiving at least one antithrombotic medication and vascular risk factor management) but still had recurrent (2 or more) ischemic strokes during the medical treatment period within past year

• Vascular diameter proximal to the stenosis must be measured at 2.0-4.0 millimeters (mm)

• Modified Rankin Scale (mRS) \<= 2

• Stenosis of 70%-99% on non-invasive vascular imaging or digital subtraction angiography (DSA), with normal distal vessel

• Participant is willing and able to return for all follow-up visits required by the protocol

• Participants understand the purpose and requirements of the study and have signed an informed consent form Intra procedure

• Stenosis of 70 percent (%) -99% on digital subtraction angiography (DSA), with normal distal vessel

Locations
Other Locations
China
Xuanwu Hospital, Capital Medical University
RECRUITING
Beijing
West China Hospital of Sichuan University
RECRUITING
Chengdu
Haikou People's Hospital
RECRUITING
Haikou
First Affiliated Hospital, Harbin Medical University
RECRUITING
Harbin
Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)
RECRUITING
Jinan
Qilu Hospital of Shandong University
RECRUITING
Jinan
Shandong Provincial Hospital
RECRUITING
Jinan
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
Ningbo First Hospital
RECRUITING
Ningbo
Huashan Hospital Fudan University
RECRUITING
Shanghai
Wenzhou Central Hospital
RECRUITING
Wenzhou
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Jie ZHOU
jzhou138@its.jnj.com
86 18600551010
Time Frame
Start Date: 2022-05-24
Estimated Completion Date: 2026-04-11
Participants
Target number of participants: 194
Treatments
Experimental: CERENOVUS ENTERPRISE 2 Intracranial Stent
Participants with severe symptomatic intracranial artery stenosis will be treated with CERENOVUS ENTERPRISE 2 Intracranial Stent.
Related Therapeutic Areas
Sponsors
Leads: Medos International SARL

This content was sourced from clinicaltrials.gov