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

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ClinicalTrials.gov Identifier: NCT02578069
Recruitment Status : Unknown
Verified October 2015 by Sino Medical Sciences Technology Inc..
Recruitment status was:  Active, not recruiting
First Posted : October 16, 2015
Last Update Posted : October 16, 2015
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Sino Medical Sciences Technology Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Device: NOVA Intracranial Sirolimus Eluting Stent System Device: Apollo Intracranial Stent System Phase 2 Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : August 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental
NOVA Intracranial sirolimus eluting stent system
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.
Active Comparator: Control
Apollo Intracranial stent system
Device: Apollo Intracranial Stent System
A 316L stainless steel balloon-expandable intracranial stent system



Primary Outcome Measures :
  1. In stent restenosis rate (> 50% restenosis) [ Time Frame: 12 months post-procedure ]
    Angiography assessment at 12 months post-procedure


Secondary Outcome Measures :
  1. Stroke and death events [ Time Frame: within 30 days after stenting ]
  2. Target vessel ischemic stroke event [ Time Frame: between 30 days and 1 year post-procedure ]
  3. Acute procedural success rate (stenosis < 30%) [ Time Frame: 1 year ]
  4. Target vessel stroke or death events [ Time Frame: within 30 days after stenting ]
  5. Non-target vessels ischemic stroke event [ Time Frame: between 30 days and 1 year post-procedure ]
  6. Recurrent ischemic stroke in the involved vascular area [ Time Frame: between 30 days and 1 year post-procedure ]
  7. Cerebral parenchyma hemorrhage, subarachnoid hemorrhage and intraventricular bleeding events [ Time Frame: between 30 days and 1 year post-procedure ]
  8. Death event [ Time Frame: between 30 days and 1 year post-procedure ]
  9. Transient ischemic attack event [ Time Frame: within 1 year post-procedure ]
  10. National Institutes of Health Stroke Scale (NIHSS) evaluation [ Time Frame: at 1 and 12 months ]
  11. modulate RANK score (mRS)evaluation [ Time Frame: at 1 and 12 months ]
  12. Montreal Cognitive Assessment (MoCA) evaluation [ Time Frame: at 1 and 12 months ]
  13. EQ-5D score evaluation [ Time Frame: at 12 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02578069


Locations
China
Beijing Tiantan Hospital
Beijing, China, 100050
Sponsors and Collaborators
Sino Medical Sciences Technology Inc.
Beijing Tiantan Hospital
Investigators
Principal Investigator: Yongjun Wang, M.D. Beijing Tiantan Hospital
Principal Investigator: Zhongrong Miao, M.D. Beijing Tiantan Hospital

Responsible Party: Sino Medical Sciences Technology Inc.
ClinicalTrials.gov Identifier: NCT02578069     History of Changes
Other Study ID Numbers: NOVA-001
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by Sino Medical Sciences Technology Inc.:
Ischemic Stroke
Intracranial Stenting

Additional relevant MeSH terms:
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs