Trial · NCT04171570
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Forearm radial artery occlusion (RAO) rate before discharge | up to 5 days | Forearm radial artery occlusion (RAO) rate before discharge measured with Doopler Ultrasound |
| Secondary | Rate of successful sheath insertion | up to 2 days | Rate of successful sheath insertion obtained though eCRF question |
| Secondary | Rate of access site crossover | up to 2 days | Rate of access site crossover - if the initial access point fails physician can perform the procedure using other access site of his/her choice This data point is captured on the eCRF |
| Secondary | Total procedural time | up to 2 days | Total procedural time defined as the time between initiation of local anesthesia to sheath removal - information captured on the eCRF |
| Secondary | Sheath insertion time | up to 2 days | Sheath insertion time recorded in the eCRF and defined as when puncture with the introducer needle first attempted until the time when introducer sheath is successfully inserted |
| Secondary | Puncture site bleeding according to EASY criteria | up to 5 days | Puncture site bleeding according to EASY criteria |
| Secondary | Overall bleeding according to BARC criteria | up to 5 days | Overall bleeding according to BARC criteria |
| Secondary | Vascular access-site complication | up to 5 days | Vascular access-site complication documented on the eCRF. It is composed by the rate of vessel perforation after occlusion requiring intervention, arterial dissection, pseudoaneurysm, and local haematoma |
| Secondary | Rate of radial artery spasm | up to 2 days | Rate of radial artery spasm captured in the eCRF. Radial arety spasm is defined as an inability to manipulate the guidewire or catheter in a smooth and pain-free manner and also as an inability to remove the sheath in a similar way at the end of the procedure |
| Secondary | Rate of distal radial artery occlusion (dRAO) | up to 5 days | Rate of distal radial artery occlusion (dRAO) by doopler ultrasound and capture in the eCRF |
| Secondary | Patent hemostasis was achieved or not (CTRA) by reverse barbeau test | up to 5 days | Patent hemostasis was achieved or not (CTRA) by reverse barbeau test |
| Secondary | Time required to reach hemostasis | up to 5 days | Time required to reach hemostasis, captured on the eCRF and defined as the time between sheath removal to complete hemostasis |
| Secondary | Pain associated with the procedure: Visual Assessment Scale (VAS) | up to 5 days | Pain associated with the procedure measured by the Visual Assessment Scale (VAS), a numeric rating scale. VAS is a 10 cm line with anchor statements on the left (no pain = 0) and on the right (worst possible pain = 10) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04171570/registered