Comparing two types of arterial sheaths for heart procedures
GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Incidence of Distal Radial Artery Occlusion in Cardiovascular Intervention Via Distal Radial Artery (SMART)
This study is testing if using a smaller type of sheath during heart procedures can help prevent blockages in the wrist artery for people undergoing cardiovascular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Wujin People's Hospital Academic / other |
| Locations | 1 site (Changzhou, Jiangsu) |
| Trial ID | NCT05501925 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the GlideSheath Slender® compared to a conventional 6 French arterial sheath in reducing the incidence of distal radial artery occlusion during cardiovascular interventions using the distal transradial artery (dTRA) approach. The dTRA approach has been shown to lower the risk of radial artery occlusion, and this study aims to determine if a smaller outer diameter sheath can further minimize complications. Participants will be monitored for outcomes related to artery occlusion following the use of these sheaths in procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years and older with a palpable distal radial and conventional radial artery.
Not a fit: Patients over 90 years old, those with specific contraindications, or those with certain heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and reduced complications for patients undergoing cardiovascular interventions.
How similar studies have performed: Previous studies have shown promising results with the dTRA approach, but the specific comparison of these two sheaths is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Palpable distal radial and conventional radial artery Exclusion Criteria: * Age ≥ 90years * Height≥ 185cm * ST-segment elevation myocardial infarction or Cardiogenic shock * Contraindications to puncture at the puncture site * Diameter of DRA less than 1.5mm or RAO
Where this trial is running
Changzhou, Jiangsu
- Changzhou Wujin People's Hospital — Changzhou, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Gaojun Cai, Dr.
- Email: cgj982@126.com
- Phone: 086-0519-85579193
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.