Designing and manufacturing of an inflatable thigh strap and evaluating its effectiveness on hemostasis during sheet removal and prevention of complications after transfemoral coronary angiography.

Designing and manufacturing of an inflatable thigh strap and evaluating its effectiveness on hemostasis during sheet removal and prevention of complications after transfemoral coronary angiography in patients referring to hospital.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200410047011N2

Enrollment

Registered

2022-12-13

Start date

2020-10-22

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

patients with coronary artery disease undergoing transfemoral coronary angiography. Cardiac catheterization as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure

Interventions

Intervention 1: Intervention group: In the test group, an inflatable thigh starp was used to maintain hemostasis and prevent bleeding and hematoma immediately after the removal of the femoral sheath a

Eligibility

Sex/Gender

All

Age

45 Years to 70 Years

Inclusion criteria

Inclusion criteria: being alert not suffering from hemophilia and coagulation disorders age between 45 and 70 years candidate for femoral angiography

Exclusion criteria

Exclusion criteria: refusal to continue cooperation the occurrence of complications such as bleeding hematoma, and abnormal pain during the intervention use of painkillers or narcotics before, during, and after transfemoral coronary angiography.

Design outcomes

Primary

Measure	Time frame
Groin pain: groin pain refers to a feeling of discomfort in the area where the abdomen ends and the legs begin. Timepoint: Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hours, two and a half hours, three hours, three hours and a half, four hours, four and a half hours, five hours, and six hours after closing the FemoStop device, totally of 12 times) recorded and reported all possible complications. Method of measurement: The Visual Analog Scale will be used to measure groin pain. The Visual Analog Scale is used to measure pain. The visual analog scale is the evaluation of pain intensity as a 10 cm horizontal line numbered from 0 to 10 (zero indicates the absence of pain and 10 indicates the most severe pain possible).;Hematoma: Localized bleeding outside the blood vessels, which occurs due to illness or trauma, including injury or surgery, and may lead to continued bleeding from broken capillaries. The hematoma is benign and initially spreads as fluid between tissues, including the interstitial sacs, which may coagulate and solidify in the blood vessels before reabsorption. Timepoint: Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hours, two and a half hours, three hours, three hours and a half, four hours, four and a half hours, five hours, and six hours after closing the FemoStop device, totally of 12 times) recorded and reported all possible complications. Method of measurement: The Christensen scale was used to measure hematoma.;Leg pain: Prickle, cramping, fatigue and sometimes burning in the legs caused by poor blood circulation in the arteries of the legs. Timepoint: Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hou	—

Measure

Time frame

Groin pain: groin pain refers to a feeling of discomfort in the area where the abdomen ends and the legs begin. Timepoint: Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hours, two and a half hours, three hours, three hours and a half, four hours, four and a half hours, five hours, and six hours after closing the FemoStop device, totally of 12 times) recorded and reported all possible complications. Method of measurement: The Visual Analog Scale will be used to measure groin pain. The Visual Analog Scale is used to measure pain. The visual analog scale is the evaluation of pain intensity as a 10 cm horizontal line numbered from 0 to 10 (zero indicates the absence of pain and 10 indicates the most severe pain possible).;Hematoma: Localized bleeding outside the blood vessels, which occurs due to illness or trauma, including injury or surgery, and may lead to continued bleeding from broken capillaries. The hematoma is benign and initially spreads as fluid between tissues, including the interstitial sacs, which may coagulate and solidify in the blood vessels before reabsorption. Timepoint: Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hours, two and a half hours, three hours, three hours and a half, four hours, four and a half hours, five hours, and six hours after closing the FemoStop device, totally of 12 times) recorded and reported all possible complications. Method of measurement: The Christensen scale was used to measure hematoma.;Leg pain: Prickle, cramping, fatigue and sometimes burning in the legs caused by poor blood circulation in the arteries of the legs. Timepoint: Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hou

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHojjat Niknam Sarabi

Artesh University of Medical Sciences

Offface92@gmail.com+98 21 8830 7020

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026