Common Femoral Artery InjuryNCT02214030

Efficacy Study of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis

A study testing Assiut Femoral Compression Device in people with Common Femoral Artery Injury and Other Vascular Adverse Event, run by Assiut University at 1 site in Egypt.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This study was performed to evaluate the safety and efficacy of a locally designed Assiut Femoral Compression Device (AFCD) versus manual compression (MC). Femoral compression devices have been developed thorough the past decades without being strongly implemented in the catheterization laboratory. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Common Femoral Artery Injury, Other Vascular Adverse Event
What is being tested?: Assiut Femoral Compression Device
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteEgypt
Study dates: Sep 2013to Dec 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients between 18 and 85 years of age,
Scheduled to undergo an elective PCI via arterial puncture of common femoral artery were eligible for enrollment in the study.
Elective PCI was defined as any coronary revascularization in a low-risk patient who presents to the facility for a planned PCI or for a coronary angiogram followed by ad hoc PCI.

Who cannot join

Patients were excluded from the study if the patient has
Any procedural complication included:
prolonged chest pain,
transient coronary artery closure, no-flow or slow-flow phenomenon,
hemodynamic instability,
persistent electrocardiographic changes,

Show all 19Show fewer

side-branch occlusion of >1.5 mm, or
an angiographically suboptimal result,
Arterial access other than the right or left femoral artery ,
Vascular perforation, thrombosis during procedure ,
Patients with high risk of puncture site complications as:
Bleeding diathesis,
International normalized ratio >1.5,
Recent thrombolysis,
Low platelet count,
Hematoma at the end of the procedure,
Previous iliofemoral artery surgery or any peripheral vascular Surgery,
Previous femoral artery complication from angiography, and
Uncontrolled hypertension at time of procedure (>180/>110).

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Assiut University Hospitals
Asyut, 71526

Other trials in Egypt

About this study

Official title: A Randomized Comparison of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis After Percutaneous Coronary Intervention

Read the detailed description

The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols. However for AFCD group, the sheaths were removed 2 hours after PCI instead of conventional 6 hours. To standardize compression times, AFCD were applied to patient and complete femoral artery compression were applied for 5 minutes, followed by a gradual release of pressure till distal pulse is palpated. Each patient received a minimum of 13 minutes of compression, with further compression applied only if full hemostasis had not been achieved at that point with maximum of 30 minutes.

Conditions: Common Femoral Artery Injury, Other Vascular Adverse Event
Being tested: Assiut Femoral Compression Device
Keywords: Femoral compression device, manual compression, arterial hemostasis, coronary intervention, coronary artery disease
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Assiut Femoral Compression DeviceDevice
Also called AFCD
Assiut Femoral Compression Devices (AFCD) is a femoral compression system, The pressure dome is situated over the vessel puncture site in the groin and applies a mechanical pressure over the vessel puncture site to induce hemostasis.

Study groups in NCT02214030
Study group	Role	What they receive
Assiut Femoral Compression Device	Active comparator	the sheaths were removed 2 hours after PCI instead of conventional 6hours. To standardize compression times, AFCD were applied to patient and complete femoral artery compression were applied for 5 minutes, followed by a gradual release of pressure over the ensuing 8 minutes. Therefore each patient received a minimum of 13 minutes of compression, with further compression applied only if full hemostasis had not been achieved at that point with maximum of 30 minutes. Receives: Device: Assiut Femoral Compression Device
Manual compression	Placebo comparator	The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols. Receives: Device: Assiut Femoral Compression Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Time-To-Ambulation (TTA), measured in hours
Ambulation was defined as patient standing and walking at least 6 meters (20 feet) without re-bleeding or significant oozing requiring manual compression
Measured: TTA was measured from the time the introducer sheath was removed (2 hr in AFCD group and 6 hours in MC group after end of PCI) to time of ambulation
the absence of major adverse events on discharge
major adverse event (MAE) was defined as symptomatic bleeding associated with hemoglobin drop ≥5 g/dL requiring blood transfusion, fatal bleeding that directly results in death, a pseudoaneurysm or arteriovenous fistula, distal arterial embolism, infections requiring administration of IV antibiotics or debridement, and the need for vascular surgery.
Measured: 24 post procedure

Secondary outcomes (2)

Device success:
This was defined as easy application of the device with good fixation and stability and achieving final hemostasis. Device Stability was defined as absence of tilt and/or mobility after application of the device on top of the patient groin. Assessment of the device application was performed using a questionnaire with a scale of three grades; "Easy", "Difficult" and "Requires Improvement". Assessment of stability and fixation of the device was performed on a scale defined as "Very Good", "Good" and "Bad".
Measured: 5 minutes during application
Procedure success
This was defined as hemostasis achieved by the assigned method, without the occurrence of a closure-related major adverse event (MAE).
Measured: 24 h post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Dec 2018

First posted12 Aug 2014 (estimated)
Study startSep 2013
Primary completionDec 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Common Femoral Artery InjuryStudies of the same condition, open and under way.
More trials run by Assiut UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02214030
Sponsor's protocol ID: AFCD-03
Other IDs: AUH-03
Status last verified: Jul 2021
First submitted: 26 Jul 2014
Last updated: 20 Jul 2021
Results posted: No
Data monitoring committee: Yes

Publications

Hassan AKM, Hasan-Ali H, Ali AS. A new femoral compression device compared with manual compression for bleeding control after coronary diagnostic catheterizations. The Egyptian Heart Journal. 2013 (in-press).

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Comparison of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis After Percutaneous Coronary Intervention
ClinicalTrials.gov ID: NCT02214030
Acronym / sponsor ID: AFCD-03
Conditions: Common Femoral Artery Injury, Other Vascular Adverse Event
Keywords: Femoral compression device, manual compression, arterial hemostasis, coronary intervention, coronary artery disease
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: Assiut UniversityUniversity, hospital or other
Study start: Sep 2013 (actual)
Primary completion: Dec 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 12 Aug 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Assiut Femoral Compression Device	Active comparator	Device: Assiut Femoral Compression Devicethe sheaths were removed 2 hours after PCI instead of conventional 6hours. To standardize compression times, AFCD were applied to patient and complete femoral artery compression were applied for 5 minutes, followed by a gradual release of pressure over the ensuing 8 minutes. Therefore each patient received a minimum of 13 minutes of compression, with further compression applied only if full hemostasis had not been achieved at that point with maximum of 30 minutes.
Manual compression	Placebo comparator	Device: Assiut Femoral Compression DeviceThe intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients between 18 and 85 years of age,
Scheduled to undergo an elective PCI via arterial puncture of common femoral artery were eligible for enrollment in the study.
Elective PCI was defined as any coronary revascularization in a low-risk patient who presents to the facility for a planned PCI or for a coronary angiogram followed by ad hoc PCI.

Key exclusion criteria (19 listed)

Patients were excluded from the study if the patient has
Any procedural complication included:
Arterial access other than the right or left femoral artery ,
Vascular perforation, thrombosis during procedure ,
Patients with high risk of puncture site complications as:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Assiut Femoral Compression DeviceAlso: AFCDAssiut Femoral Compression Devices (AFCD) is a femoral compression system, The pressure dome is situated over the vessel puncture site in the groin and applies a mechanical pressure over the vessel puncture site to induce hemostasis.	Device	Assiut Femoral Compression Device, Manual compression

Primary outcome

Time-To-Ambulation (TTA), measured in hours
Time frame: TTA was measured from the time the introducer sheath was removed (2 hr in AFCD group and 6 hours in MC group after end of PCI) to time of ambulation
Ambulation was defined as patient standing and walking at least 6 meters (20 feet) without re-bleeding or significant oozing requiring manual compression
the absence of major adverse events on discharge
Time frame: 24 post procedure
major adverse event (MAE) was defined as symptomatic bleeding associated with hemoglobin drop ≥5 g/dL requiring blood transfusion, fatal bleeding that directly results in death, a pseudoaneurysm or arteriovenous fistula, distal arterial embolism, infections requiring administration of IV antibiotics or debridement, and the need for vascular surgery.

2 secondary outcomes

Device success:
Time frame: 5 minutes during application
Procedure success
Time frame: 24 h post procedure

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
BackgroundHassan AKM, Hasan-Ali H, Ali AS. A new femoral compression device compared with manual compression for bleeding control after coronary diagnostic catheterizations. The Egyptian Heart Journal. 2013 (in-press).

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ayman K.M. Hassan, MD. PhD. principal investigator

Assiut University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Assiut Femoral Compression Device in people with Common Femoral Artery Injury and Other Vascular Adverse Event, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-To-Ambulation (TTA), measured in hours (time frame: TTA was measured from the time the introducer sheath was removed (2 hr in AFCD group and 6 hours in MC group after end of PCI) to time of ambulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02214030, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.