Brachial AccessSANDNCT07714824
Evaluation of Shoulder Access Safety Using the NewMan Compression Device
A study testing Hemostasis is performed using a pressure bandage and Hemostasis is performed using the NewMan compression device in people with Brachial Access and Access Complication, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
The aim of the study is to evaluate the effectiveness of the NewMan compression device in shoulder access in patients with occlusive lesions of the femoral-popliteal segment of the lower extremity arteries by comparing the frequency of access complications when it is used or when a pressure bandage is used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brachial Access, Access Complication, Hemostasis Compression Device
- What is being tested?
- Hemostasis is performed using a pressure bandage and Hemostasis is performed using the NewMan compression device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteRussia
- Study dates
- 1 Aug 2024to 18 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- arterial diameter at the access site of at least 3 mm
- indications for endovascular intervention on the lower extremity arteries
- age of 18 years or more, and patient consent to participate in the study
Who cannot join
- inability to perform an access due to stenotic lesions of the above-mentioned arteries (axillary, subclavian arteries, and brachiocephalic trunk)
- height exceeding 180 cm; presence of concomitant pathology that limits patient survival; pathology of the blood coagulation system (hemophilia, thrombocytopathies, etc.)
- previous catheterizations performed through the access artery
Trial locations and contacts
1 site in 1 country.
Russia1 site
Central Clinical Hospital of St. Alexy Metropolitan of Moscow of the Moscow Patriarchate of the Russian Orthodox Church, Moscow
Moscow, 117513
About this study
The aim of the study is to evaluate the effectiveness of the NewMan compression device in shoulder access in patients with occlusive lesions of the femoral-popliteal segment of the lower extremity arteries by comparing the frequency of access complications when it is used or when a pressure bandage is used.
The objectives of the study are to answer the following main questions: 1. Does the use of a compression device in shoulder access reduce the overall number of complications compared to an occlusive bandage? 2. Does the use of a compression device during shoulder access reduce the number of complications requiring surgical intervention compared to an occlusive bandage? 3. Does the use of a compression device during shoulder access reduce the number of hematomas in the access area compared to an occlusive bandage? The researchers will compare the number of complications associated with shoulder access when using a compression device and an occlusive bandage for the revascularization of femoral-popliteal segment occlusions of the lower extremity arteries. During the routine revascularization procedure, participants will undergo a catheterization of the brachial artery. Complications related to radiation therapy will be recorded by doctors within 72 hours of the intervention.
Read the detailed description
The purpose of the study: to evaluate the effectiveness of the NewMan compression device in shoulder access in patients with occlusive lesions of the femoral-popliteal segment of the lower extremity arteries by comparing the frequency of access complications when using the device or a pressure bandage.
Scientific hypotheses: 1. The use of the compression device in shoulder access has fewer complications compared to a pressure bandage. 2. The use of the compression device in shoulder access has fewer complications requiring surgical intervention compared to a pressure bandage. 3. The use of a compression device during shoulder access has a lower incidence of hematomas compared to a pressure bandage.
Inclusion criteria: an arterial diameter of at least 3 mm at the access site, indications for endovascular intervention on the lower extremity arteries, an age of 18 years or more, and patient consent to participate in the study.
Exclusion criteria: inability to perform access due to stenotic lesions of the above-mentioned arteries (axillary, subclavian arteries, brachiocephalic trunk); height exceeding 180 cm; presence of concomitant pathology limiting patients' survival; pathology of the blood coagulation system (hemophilia, thrombocytopathies, etc.), previously performed catheterization through the access artery.
The required sample size was calculated using the M. Blanda method for a study with increased accuracy. The required significance level (α) was 0.05, and the study's power was 95%. The estimated complication rates in the Brachial and NewMan groups were assumed to be 11% and 1%, respectively. Under these conditions, the estimated sample size was 141 patients. The planned loss rate during the study was 5%. Therefore, the minimum sample size was 148 patients.
The study has an experimental design and follows the CONSORT protocol. A simple method of randomization using a random number generator was selected.
The puncture of the brachial artery was performed under ultrasound control. The choice of hemostasis method was made by randomization using a random number generator, depending on this, the patient was assigned to one of the groups: a group using a compression device NewMan - NewMan or a pressure bandage - Brachial. The brachial artery was catheterized 2-3 cm above the elbow flexion. The following instruments were used to perform the intervention: an 18G angiographic needle 7 cm long, a 0.035-inch diagnostic guide 260 cm, a 6 Fr 90 cm guide introducer (Destination, manufacturer Terumo), diagnostic catheters 5 Fr in diameter and 125 cm in length (Optitorque, manufacturer Terumo or Impress, manufacturer Merit Medical), peripheral conductors 0.035 or 0.018 inches, balloon catheters with a delivery length of 150 cm and 180 cm (Atropos, manufacturer of BrosMed; Pacific Plus, manufacturer of Medtronic) and balloon catheters for peripheral arteries with a drug coating of paclitaxel and a delivery system length of 150 cm (Ranger, manufacturer of Boston Scientific). 5,000 IU of heparin in saline solution was injected into the catheterized artery. Hemostasis was achieved by applying a classic pressure bandage or using the NewMan compression device (manufactured by NewMan Technologies, Russia).
A control examination of the access site was performed within 3 hours after the end of the intervention, and then, if there were no complaints, when the bandage was removed. After the bandage was removed, the patients underwent an ultrasound examination. Complications were recorded within 3 days after the intervention.
- Conditions
- Brachial Access, Access Complication, Hemostasis Compression Device, Atherosclerosis of the Arteries of the Lower Extremities
- Being tested
- Hemostasis is performed using a pressure bandage, Hemostasis is performed using the NewMan compression device
- Keywords
- atherosclerosis of the arteries of the lower extremities, occlusion of the femoral-popliteal segment, endovascular treatment, brachial access, access complications, compression device, hemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemostasis is performed using a pressure bandageProcedure or surgery
The puncture of the brachial artery was performed under ultrasound control. The brachial artery was catheterized 2-3 cm above the elbow crease. The following instruments were used to perform the intervention: an 18G angiographic needle 7 cm long, a 0.035-inch diagnostic guide 260 cm, a 6 Fr 90 cm guide introducer (Destination, manufacturer Terumo), diagnostic catheters 5 Fr in diameter and 125 cm in length (Optitorque, manufacturer Terumo or Impress, manufacturer Merit Medical), peripheral conductors 0.035 or 0.018 inches, balloon catheters with a delivery length of 150 cm and 180 cm (Atropos, manufacturer of BrosMed; Pacific Plus, manufacturer of Medtronic) and balloon catheters for peripheral arteries with a drug coating of paclitaxel and a delivery system length of 150 cm (Ranger, manufacturer of Boston Scientific). 5,000 IU of heparin in saline solution was injected into the catheterized artery. Hemostasis was achieved by applying a classic pressure bandage.
The access site was ins
Hemostasis is performed using the NewMan compression deviceProcedure or surgery
The puncture of the brachial artery was performed under ultrasound control. The brachial artery was catheterized 2-3 cm above the elbow crease. The following instruments were used to perform the intervention: an 18G angiographic needle 7 cm long, a 0.035-inch diagnostic guide 260 cm, a 6 Fr 90 cm guide introducer (Destination, manufacturer Terumo), diagnostic catheters 5 Fr in diameter and 125 cm in length (Optitorque, manufacturer Terumo or Impress, manufacturer Merit Medical), peripheral conductors 0.035 or 0.018 inches, balloon catheters with a delivery length of 150 cm and 180 cm (Atropos, manufacturer of BrosMed; Pacific Plus, manufacturer of Medtronic) and balloon catheters for peripheral arteries with a drug coating of paclitaxel and a delivery system length of 150 cm (Ranger, manufacturer of Boston Scientific). 5000 IU of heparin in saline solution was injected into the catheterized artery. Hemostasis was performed using the NewMan compression device.
The access site was inspec
| Study group | Role | What they receive |
|---|---|---|
| Brachial | Active comparator | Hemostasis is performed using a pressure bandage Receives: Procedure: Hemostasis is performed using a pressure bandage |
| NewMan | Experimental | Hemostasis is performed using the NewMan compression device Receives: Procedure: Hemostasis is performed using the NewMan compression device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with hematoma at the access point with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with hematoma at the access point with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Within 72 hours after artery catheterization
Number of participants with Acute artery occlusion with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with Acute artery occlusion with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Within 72 hours after artery catheterization
Number of participants with Post-catheterization aneurysm that required surgery with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with Post-catheterization aneurysm that required surgery with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Within 72 hours after artery catheterization
Number of participants with Technical success of access
Number of participants with Technical success of access
Measured: Perioperative/Periprocedural
Number of participants with Technical success of the index procedure
Number of participants with Technical success of the index procedure
Measured: Perioperative/Periprocedural
Number of participants with Conversion to another access
Number of participants with Conversion to another access
Measured: Perioperative/Periprocedural
Secondary outcomes (2)
Total number of complications
Total number of complications
Measured: Within 72 hours after radial artery catheterization
Total number of complications that required surgery
Total number of complications that required surgery
Measured: Within 72 hours after radial artery catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Aug 2024
- Primary completion15 Jun 2026
- Study completion18 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial AccessStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandr V. Bocharov, PhD, MD, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714824
- Sponsor's protocol ID
- 261/2
- Acronym
- SAND
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all personal data underlying the publication results
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Shoulder Access Safety Using the NewMan Compression Device
- ClinicalTrials.gov ID
- NCT07714824
- Acronym / sponsor ID
- SAND / 261/2
- Conditions
- Brachial Access, Access Complication, Hemostasis Compression Device, Atherosclerosis of the Arteries of the Lower Extremities
- Keywords
- atherosclerosis of the arteries of the lower extremities, occlusion of the femoral-popliteal segment, endovascular treatment, brachial access, access complications, compression device, hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 18 Jun 2026 (actual)
- First posted
- 20 Jul 2026 (actual)
- 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.
The aim of the study is to evaluate the effectiveness of the NewMan compression device in shoulder access in patients with occlusive lesions of the femoral-popliteal segment of the lower extremity arteries by comparing the frequency of access complications when it is used or when a pressure bandage is used.
The objectives of the study are to answer the following main questions: 1. Does the use of a compression device in shoulder access reduce the overall number of complications compared to an occlusive bandage? 2. Does the use of a compression device during shoulder access reduce the number of complications requiring surgical intervention compared to an occlusive bandage? 3. Does the use of a compression device during shoulder access reduce the number of hematomas in the access area compared to an occlusive bandage? The researchers will compare the number of complications associated with shoulder access when using a compression device and an occlusive bandage for the revascularization of femoral-popliteal segment occlusions of the lower extremity arteries. During the routine revascularization procedure, participants will undergo a catheterization of the brachial artery. Complications related to radiation therapy will be recorded by doctors within 72 hours of the intervention.
Detailed description
The purpose of the study: to evaluate the effectiveness of the NewMan compression device in shoulder access in patients with occlusive lesions of the femoral-popliteal segment of the lower extremity arteries by comparing the frequency of access complications when using the device or a pressure bandage.
Scientific hypotheses: 1. The use of the compression device in shoulder access has fewer complications compared to a pressure bandage. 2. The use of the compression device in shoulder access has fewer complications requiring surgical intervention compared to a pressure bandage. 3. The use of a compression device during shoulder access has a lower incidence of hematomas compared to a pressure bandage.
Inclusion criteria: an arterial diameter of at least 3 mm at the access site, indications for endovascular intervention on the lower extremity arteries, an age of 18 years or more, and patient consent to participate in the study.
Exclusion criteria: inability to perform access due to stenotic lesions of the above-mentioned arteries (axillary, subclavian arteries, brachiocephalic trunk); height exceeding 180 cm; presence of concomitant pathology limiting patients' survival; pathology of the blood coagulation system (hemophilia, thrombocytopathies, etc.), previously performed catheterization through the access artery.
The required sample size was calculated using the M. Blanda method for a study with increased accuracy. The required significance level (α) was 0.05, and the study's power was 95%. The estimated complication rates in the Brachial and NewMan groups were assumed to be 11% and 1%, respectively. Under these conditions, the estimated sample size was 141 patients. The planned loss rate during the study was 5%. Therefore, the minimum sample size was 148 patients.
The study has an experimental design and follows the CONSORT protocol. A simple method of randomization using a random number generator was selected.
The puncture of the brachial artery was performed under ultrasound control. The choice of hemostasis method was made by randomization using a random number generator, depending on this, the patient was assigned to one of the groups: a group using a compression device NewMan - NewMan or a pressure bandage - Brachial. The brachial artery was catheterized 2-3 cm above the elbow flexion. The following instruments were used to perform the intervention: an 18G angiographic needle 7 cm long, a 0.035-inch diagnostic guide 260 cm, a 6 Fr 90 cm guide introducer (Destination, manufacturer Terumo), diagnostic catheters 5 Fr in diameter and 125 cm in length (Optitorque, manufacturer Terumo or Impress, manufacturer Merit Medical), peripheral conductors 0.035 or 0.018 inches, balloon catheters with a delivery length of 150 cm and 180 cm (Atropos, manufacturer of BrosMed; Pacific Plus, manufacturer of Medtronic) and balloon catheters for peripheral arteries with a drug coating of paclitaxel and a delivery system length of 150 cm (Ranger, manufacturer of Boston Scientific). 5,000 IU of heparin in saline solution was injected into the catheterized artery. Hemostasis was achieved by applying a classic pressure bandage or using the NewMan compression device (manufactured by NewMan Technologies, Russia).
A control examination of the access site was performed within 3 hours after the end of the intervention, and then, if there were no complaints, when the bandage was removed. After the bandage was removed, the patients underwent an ultrasound examination. Complications were recorded within 3 days after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brachial | Active comparator | Procedure: Hemostasis is performed using a pressure bandageHemostasis is performed using a pressure bandage |
| NewMan | Experimental | Procedure: Hemostasis is performed using the NewMan compression deviceHemostasis is performed using the NewMan compression device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- arterial diameter at the access site of at least 3 mm
- indications for endovascular intervention on the lower extremity arteries
- age of 18 years or more, and patient consent to participate in the study
Key exclusion criteria (3 listed)
- inability to perform an access due to stenotic lesions of the above-mentioned arteries (axillary, subclavian arteries, and brachiocephalic trunk)
- height exceeding 180 cm; presence of concomitant pathology that limits patient survival; pathology of the blood coagulation system (hemophilia, thrombocytopathies, etc.)
- previous catheterizations performed through the access artery
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 |
|---|---|---|
| Hemostasis is performed using a pressure bandageThe puncture of the brachial artery was performed under ultrasound control. The brachial artery was catheterized 2-3 cm above the elbow crease. The following instruments were used to perform the intervention: an 18G angiographic needle 7 cm long, a 0.035-inch diagnostic guide 260 cm, a 6 Fr 90 cm guide introducer (Destination, manufacturer Terumo), diagnostic catheters 5 Fr in diameter and 125 cm in length (Optitorque, manufacturer Terumo or Impress, manufacturer Merit Medical), peripheral conductors 0.035 or 0.018 inches, balloon catheters with a delivery length of 150 cm and 180 cm (Atropos, manufacturer of BrosMed; Pacific Plus, manufacturer of Medtronic) and balloon catheters for peripheral arteries with a drug coating of paclitaxel and a delivery system length of 150 cm (Ranger, manufacturer of Boston Scientific). 5,000 IU of heparin in saline solution was injected into the catheterized artery. Hemostasis was achieved by applying a classic pressure bandage. The access site was ins | Procedure or surgery | Brachial |
| Hemostasis is performed using the NewMan compression deviceThe puncture of the brachial artery was performed under ultrasound control. The brachial artery was catheterized 2-3 cm above the elbow crease. The following instruments were used to perform the intervention: an 18G angiographic needle 7 cm long, a 0.035-inch diagnostic guide 260 cm, a 6 Fr 90 cm guide introducer (Destination, manufacturer Terumo), diagnostic catheters 5 Fr in diameter and 125 cm in length (Optitorque, manufacturer Terumo or Impress, manufacturer Merit Medical), peripheral conductors 0.035 or 0.018 inches, balloon catheters with a delivery length of 150 cm and 180 cm (Atropos, manufacturer of BrosMed; Pacific Plus, manufacturer of Medtronic) and balloon catheters for peripheral arteries with a drug coating of paclitaxel and a delivery system length of 150 cm (Ranger, manufacturer of Boston Scientific). 5000 IU of heparin in saline solution was injected into the catheterized artery. Hemostasis was performed using the NewMan compression device. The access site was inspec | Procedure or surgery | NewMan |
Primary outcome
Number of participants with hematoma at the access point with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Within 72 hours after artery catheterization
Number of participants with hematoma at the access point with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with Acute artery occlusion with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Within 72 hours after artery catheterization
Number of participants with Acute artery occlusion with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with Post-catheterization aneurysm that required surgery with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Within 72 hours after artery catheterization
Number of participants with Post-catheterization aneurysm that required surgery with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with Technical success of access
Time frame: Perioperative/Periprocedural
Number of participants with Technical success of access
Number of participants with Technical success of the index procedure
Time frame: Perioperative/Periprocedural
Number of participants with Technical success of the index procedure
Number of participants with Conversion to another access
Time frame: Perioperative/Periprocedural
Number of participants with Conversion to another access
2 secondary outcomes
Total number of complications
Time frame: Within 72 hours after radial artery catheterization
Total number of complications that required surgery
Time frame: Within 72 hours after radial artery catheterization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Yes. all personal data underlying the publication results
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemostasis is performed using a pressure bandage and Hemostasis is performed using the NewMan compression device in people with Brachial Access and Access Complication, run by Pirogov Russian National Research Medical University at 1 site in Russia.
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 3 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: finished, as of the sponsor's last update on 24 Jul 2026. 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 Russia. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with hematoma at the access point with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Within 72 hours after artery catheterization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.