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Exploratory research to shorten bed rest time after catheter treatment by femoral artery using a groin compression device (Rebelt)

Exploratory research to shorten bed rest time after transfemoral artery angiography using a groin compression device (Rebelt) - Rebelt study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052220199
Enrollment
200
Registered
2023-03-20
Start date
2023-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative hemorrhage transfemoral artery approach, endovascular theraphy, bed rest time

Interventions

After catheter therapy or angiography via the transfemoral artery approach, continuous compression hemostasis is performed with a groin compression device to reduce the bed rest time compared to conve
hemostasis, groin compression device, reduce the bed rest time

Sponsors

Gentsu Tomoyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who perform catheter therapy or angiography via trans-femoral artery approach and fulfill the following; 1) A 4 or 5Fr. sheath is used. 2) Temporary hemostasis is achieved without abnormality by manual compression at the time of sheath removal. 3) Compression is started using a rebelt after temporary hemostasis. 2. The patient is at least 18 years of age at the time consent is obtained. 3. Written consent for participation in this clinical research has been obtained from the patient.

Exclusion criteria

Exclusion criteria: 1. Patients taking two or more antiplatelet or anticoagulant drugs and unable to discontinue medications or reduce dose to aspirin only prior to the procedure. 2. Patients with high bleeding risk (platelet count = 1.5). 3. Intraoperative use of heparin and ACT at the time of sheath removal is >180 seconds or not measured. 4. There are pain, a surgical wound, hernia, or other abnormality at the planned puncture site. 5. Inability to maintain supine rest after procedure. 6. Difficulty in communicating. 7. Other patients deemed inappropriate as research subjects by the investigators.

Design outcomes

Primary

MeasureTime frame
Presence/absence of hemorrhagic adverse events

Secondary

MeasureTime frame
Presence/absence of non-hemorrhagic adverse events Presence/absence of minor bleeding adverse events Presence/absence of physical and mental distress

Contacts

Public ContactKoji Sasaki

Kobe University Hospital

deprad-ivr-research@med.kobe-u.ac.jp+81-78-382-6104

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026