First-in-man Trial Evaluating the Safety and Efficacy of the NOVA Intracranial Stent (NOVA Trial)

Ischemic Stroke Clinical Trial

— NOVA  

Official title:

A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of the NOVA Sirolimus Eluting Stent Versus the Apollo Stent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578069
• Other study ID #: NOVA-001
• Status: Completed
• Phase: N/A
• Start date: April 27, 2015
• Est. completion date: January 2020

Study information

• Verified date: January 2019
• Source: Sino Medical Sciences Technology Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multi-center, randomized 1:1 single blind trial using NOVA sirolimus eluting stent versus Apollo bare metal stent conducted in approximately 15 interventional neurology centers in China. The study was sponsored by Sino Medical Sciences Technology Inc.

Description:

The study will enroll 264 subjects overall in two groups (randomized 1:1). The study follow-up will occur at 1, 6 and 12 months post-stent implantation. All patients will undergo angiography assessment (DSA/CTA) at 12 months follow-up. Angiography assessment will be performed at baseline (pre- and post-procedure) and 12 months follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18 to 75 years of age;

2. Primary or recurrent symptomatic intracranial arteriostenosis through the internal medicine treatment (i.e. stroke or transient ischemic attack within 90 days during the treatment with at least one anti-thrombotic drugs and vascular risk factor intervention e.g. hypertensors for hypertension and hypolipidemics for hyperlipidemia);

3. No transient ischemic attack (TIA) or ischemic stroke occurred within 2 weeks prior to stenting procedure;

4. =70% stenosis of intracranial responsible vessel under the DSA angiography (as judged through the WASID method);

5. Poor blood circulation in the side branch of responsible vessel area under the angiography within one week prior to stenting procedure:

Score of blood circulation in the side branch under the DSA <3 or blood flow rate peak =200cm/s at the systolic phase under the transcranial doppler ultrasonic examination (TCD); or no apparent side branch compensation in the responsible vessel area under CTA or score of blood circulation in the side branch under the CTA <2;

6. The target lesion reference diameter must be visually estimated to be =2.0 mm in diameter, and lesion length must be <15 mm; no lesion observed in the distal vessel;

7. Atherosclerosis lesions;

8. mRS < 3;

9. Written informed consent.

Exclusion Criteria:

1. >70% intracranial large-vessel stenosis beyond the responsible vessel;

2. >70% stenosis observed at the intracranial large-vessel distal to the responsible vessel or >70% stenosis observed at the intracranial/extracranial large-vessel proximal to the responsible vessel;

3. Acute ischemic stroke within 3 weeks;

4. Obstruction of perforating branch artery under the skull MRI;

5. Intracranial hemorrhage in the angiopathic area within 6 weeks;

6. Patient was treated by thrombolytic therapy within 24 hours;

7. Patients underwent surgery within 30 days or plan for surgery within 3 months post-stenting procedure;

8. Severe calcified lesions;

9. Patients have been treated by intracranial/extracranial stenting procedures prior to this study;

10. Nonatherosclerosis lesions;

11. Patients with potential sources for cardiac embolism;

12. Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation;

13. Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study, sirolimus, poly(lactic-co-glycolic acid) polymers, or poly(n-butyl methacrylate);

14. Hemoglobin <100g/L, platelet count <100,000 cells/mm3, International normalized ratio (INR) >1.5 (irreversible) or uncorrectable hemorrhagic factors;

15. Serious neural dysfunction due to the responsible angiopathy as the sequel of cerebral infarction (mRS=3);

16. Known liver or renal insufficiency (ALT> 3x upper limit or AST > 3x upper limit, creatinine > 1.5x upper limit);

17. Life expectancy < 2 years;

18. Pregnant/lactating female patients;

19. Patients with cognitive impairment or mental diseases;

20. The patient participated in another investigational device or drug study within 3 months;

21. Inapplicable for intravascular stenting treatment as per investigators judgment.

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Device:
• NOVA Intracranial Sirolimus Eluting Stent System
A sirolimus eluting intracranial stent system with polylactic-co-glycolic acid (PLGA) biodegradable drug carrier and electro-grated polybutyl methacrylate (PBMA) base coating. The stent platform is made of 316L stainless steel.
• Apollo Intracranial Stent System
A 316L stainless steel balloon-expandable intracranial stent system

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Sino Medical Sciences Technology Inc.	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In stent restenosis rate (> 50% restenosis)	Angiography assessment at 12 months post-procedure	12 months post-procedure
Secondary	Stroke and death events		within 30 days after stenting
Secondary	Target vessel ischemic stroke event		between 30 days and 1 year post-procedure
Secondary	Acute procedural success rate (stenosis < 30%)		1 year
Secondary	Target vessel stroke or death events		within 30 days after stenting
Secondary	Non-target vessels ischemic stroke event		between 30 days and 1 year post-procedure
Secondary	Recurrent ischemic stroke in the involved vascular area		between 30 days and 1 year post-procedure
Secondary	Cerebral parenchyma hemorrhage, subarachnoid hemorrhage and intraventricular bleeding events		between 30 days and 1 year post-procedure
Secondary	Death event		between 30 days and 1 year post-procedure
Secondary	Transient ischemic attack event		within 1 year post-procedure
Secondary	National Institutes of Health Stroke Scale (NIHSS) evaluation		at 1 and 12 months
Secondary	modulate RANK score (mRS)evaluation		at 1 and 12 months
Secondary	Montreal Cognitive Assessment (MoCA) evaluation		at 1 and 12 months
Secondary	EQ-5D score evaluation		at 12 months