Distal Radial Artery Access With 6F and 7F Thin-Walled Sheaths for Coronary Intervention: A Multicentre, Randomized, DRAWS Trial Protocol
Bibliographic record
Abstract
Distal radial artery access (dTRA) reduces radial artery occlusion (RAO) and improves safety compared with conventional transradial access, yet its use in complex coronary interventions necessitating larger guiding catheters remains limited. Thin-walled 7F sheaths with reduced external diameter may overcome this barrier. We present the protocol for a multicentre, randomized, open-label, noninferiority trial enrolling 574 patients aged 18 to 80 years with distal radial artery diameter ≥ 1.7 mm who are scheduled for elective percutaneous coronary intervention (PCI) across 5 Chinese centres. Participants are centrally randomized 1:1 to receive either a 7F thin-walled sheath (experimental) or a 6F thin-walled sheath (control) via dTRA. The primary endpoint is RAO and distal RAO at 24 hours, evaluated by Doppler ultrasound. Secondary endpoints include cannulation and procedural success, crossover to alternative access, RAO and distal RAO at 30 days, hematoma (EASY scale), major bleeding (BARC), pain (VAS), functional status (Barthel Index), length of stay, and total hospitalization costs. Data are collected pre-, intra-, and postprocedure, with follow-up at 24 hours and 30 days. Results will provide robust evidence on the safety and efficacy of 7F thin-walled sheaths in dTRA for complex PCI, informing optimal equipment selection and procedural strategies. CLINICAL TRIAL REGISTRATION: NCT06585917.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".