Search / Trial NCT06614972

Balloon-expandable DES for ICAS Registry Study (BDES-ICAS Registry)

Launched by RENJI HOSPITAL · Sep 23, 2024

Trial Information

Current as of December 22, 2024

Not yet recruiting

Keywords

Intracranial Atherosclerosis Stroke Drug Eluting Stent

ClinConnect Summary

This study is a prospective, multi-center, real world, registry study. This study aimed to evaluate the effectiveness of balloon-expandable drug-eluting stents in treating stenosis in the C2-C7 segments of the internal carotid artery and V4 artery which with high prevalence of calcified plaques in ICAD.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age ≥ 18 years.
  • 2. According to clinical and angiographic evidence, symptomatic intracranial arteries stenosis within 3 months include vertebral artery V4 segment or internal carotid artery C2-C7 segment, and the degree of diseased arterial stenosis is between 70%\~99% (WASID method).
  • 3. Patients have more than 1 episode of symptoms including stroke or transient ischemia attack (TIA) after intensive medical treatment (including antiplatelet therapy, antihypertensive, hypoglycemic and lipid-lowering treatments).
  • 4. Patients have at least 1 risk factor for intracranial atherosclerosis, including previous or existing hypertension, hyperlipidemia, diabetes mellitus, smoking, alcohol consumption, obesity, underlying heart disease, family history of atherosclerotic vascular disease, hyperhomocysteinemia and so on.
  • 5. Baseline mRS score ≤3.
  • 6. Patient or guardian signs informed consent.
  • Exclusion Criteria:
  • 1. Patients who cannot receive dual antiplatelet therapy due to existing diseases or with server coagulation dysfunction, uncontrolled serious infections, serious systemic diseases, uncontrollable hypertension and other conditions are not suitable for surgery.
  • 2. Patients with aneurysm that cannot be treated in advance or at the same time or are not suitable for surgery.
  • 3. Gastrointestinal disease with active bleeding.
  • 4. Myocardial infarction or massive cerebral infarction within 2 weeks.
  • 5. Patients with known severe allergies or contraindications to heparin, rapamycin, anesthesia and contrast media.
  • 6. Life expectancy \<12 months.
  • 7. According to the judgement of the investigator, other situations that are not suitable for enrollment.

Trial Officials

Jieqing Wan

Principal Investigator

RenJi Hospital

About Renji Hospital

Renji Hospital, a prestigious medical institution affiliated with Shanghai Jiao Tong University School of Medicine, is dedicated to advancing healthcare through innovative clinical research. With a strong emphasis on patient-centered care, Renji Hospital conducts a wide range of clinical trials across various therapeutic areas, harnessing cutting-edge technology and evidence-based practices. The hospital's multidisciplinary team of experienced researchers and medical professionals collaborates closely to ensure rigorous study design and execution, aiming to contribute significantly to medical knowledge and improve treatment outcomes for patients worldwide.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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