Vessel Puncture Site BleedingPARFEMNCT06065943
Ultrasound-guided In-plane Puncture of the Femoral Artery
A study testing Palpation and Fluoroscopy and Ultrasound guidance in people with Vessel Puncture Site Bleeding, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
In Germany almost 1 million cardiac catheterizations are performed each year. These procedures can be done either by a transradial or a transfemoral approach. Today, the transradial approach is the recommended default strategy. Nevertheless, transfemoral access ist still frequently used. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vessel Puncture Site Bleeding
- What is being tested?
- Palpation and Fluoroscopy and Ultrasound guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2022to 30 Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- transfemoral catheterization
Who cannot join
- acute myocardial infarction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Cardiology Wuerzburg University
In Germany almost 1 million cardiac catheterizations are performed each year. These procedures can be done either by a transradial or a transfemoral approach. Today, the transradial approach is the recommended default strategy. Nevertheless, transfemoral access ist still frequently used. The main draw-back of a transfemoral approach are potential access site complications, which can sometimes be life-threatening. To reduce vascular complications ultrasound guided vessel puncture may be helpful.
In the "Ultrasound guided puncture of the femoral artery"-Study (US-Parfem) an optimized method of ultrasound guided femoral puncture will be evaluated. In this randomized study the new puncture technique combining ultrasound and fluoroscopy will be compared with the conventional method guided by vessel palpation and fluoroscopy. Primary endpoint of the study is the rate of primary successful puncture of the femoral common artery above the bifurcation and below the inguinal ligament ("first success rate").
- Conditions
- Vessel Puncture Site Bleeding
- Being tested
- Palpation and Fluoroscopy, Ultrasound guidance
- Keywords
- ultrasound guided puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palpation and FluoroscopyOther
Vessel puncture guided palpation and fluoroscopy only
Ultrasound guidanceProcedure or surgery
Vessel puncture guided by Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guidance | Active comparator | Not described Receives: Procedure: Ultrasound guidance |
| Palpation and Fluoroscopy | Other | Not described Receives: Other: Palpation and Fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial successful puncture of the common femoral artery
Analysis of rotational femoral angiography
Measured: 1 week
Secondary outcomes (4)
Unsuccessful puncture attempts
number of unsuccessful puncture attempts
Measured: access-phase of the procedure
Perception of pain
pain scale between 0 (no pain) and 10 (maximum pain) graded by the patient
Measured: Evaluated at the end of the access-phase of the procedure
accidental venipuncture
Venipuncture was recognized by backflow of pulsatile and non-arterial blood
Measured: at the end of the access-phase of the procedure
Duration until successful puncture
Time frame between start of initial puncture and successful introduction of the guide-wire up to 1 minute
Measured: Evaluated at the end of the access-phase of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Jul 2022
- Primary completion31 Mar 2024
- Study completion30 Jun 2024
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 Vessel Puncture Site BleedingStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065943
- Sponsor's protocol ID
- 112/19-sc
- Acronym
- PARFEM
- Status last verified
- Aug 2024
- First submitted
- 5 Sep 2023
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Voelker W, Lachmann M, Gueder G, Bayik A, Heinrichs M, Kickuth R, Bauer WR, Lengenfelder B, Nordbeck P, Frantz S, Stork S. Can Ultrasound-Guided in-Plane Puncture Technique Enhance the Precision of Femoral Artery Access? The Randomized PARFEM Trial. Catheter Cardiovasc Interv. 2025 Oct;106(4):2252-2262. doi: 10.1002/ccd.31733. Epub 2025 Jul 30.
PubMed 40735901
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Cardiology Wuerzburg University
- ClinicalTrials.gov ID
- NCT06065943
- Acronym / sponsor ID
- PARFEM / 112/19-sc
- Conditions
- Vessel Puncture Site Bleeding
- Keywords
- ultrasound guided puncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 4 Oct 2023 (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.
In Germany almost 1 million cardiac catheterizations are performed each year. These procedures can be done either by a transradial or a transfemoral approach. Today, the transradial approach is the recommended default strategy. Nevertheless, transfemoral access ist still frequently used. The main draw-back of a transfemoral approach are potential access site complications, which can sometimes be life-threatening. To reduce vascular complications ultrasound guided vessel puncture may be helpful.
In the "Ultrasound guided puncture of the femoral artery"-Study (US-Parfem) an optimized method of ultrasound guided femoral puncture will be evaluated. In this randomized study the new puncture technique combining ultrasound and fluoroscopy will be compared with the conventional method guided by vessel palpation and fluoroscopy. Primary endpoint of the study is the rate of primary successful puncture of the femoral common artery above the bifurcation and below the inguinal ligament ("first success rate").
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guidance | Active comparator | Procedure: Ultrasound guidance |
| Palpation and Fluoroscopy | Other | Other: Palpation and Fluoroscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- transfemoral catheterization
Key exclusion criteria (1 listed)
- acute myocardial infarction
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 |
|---|---|---|
| Palpation and FluoroscopyVessel puncture guided palpation and fluoroscopy only | Other | Palpation and Fluoroscopy |
| Ultrasound guidanceVessel puncture guided by Ultrasound | Procedure or surgery | Ultrasound guidance |
Primary outcome
Initial successful puncture of the common femoral artery
Time frame: 1 week
Analysis of rotational femoral angiography
4 secondary outcomes
Unsuccessful puncture attempts
Time frame: access-phase of the procedure
Perception of pain
Time frame: Evaluated at the end of the access-phase of the procedure
accidental venipuncture
Time frame: at the end of the access-phase of the procedure
Duration until successful puncture
Time frame: Evaluated at the end of the access-phase of the procedure
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 15 Aug 2024.
- Derived from this study: PubMed 40735901Voelker W, Lachmann M, Gueder G, Bayik A, Heinrichs M, Kickuth R, Bauer WR, Lengenfelder B, Nordbeck P, Frantz S, Stork S. Can Ultrasound-Guided in-Plane Puncture Technique Enhance the Precision of Femoral Artery Access? The Randomized PARFEM Trial. Catheter Cardiovasc Interv. 2025 Oct;106(4):2252-2262. doi: 10.1002/ccd.31733. Epub 2025 Jul 30.
- Individual participant dataSharing planned: No
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 Palpation and Fluoroscopy and Ultrasound guidance in people with Vessel Puncture Site Bleeding, run by Wuerzburg University Hospital at 1 site in Germany.
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 1 inclusion and 1 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 15 Aug 2024. 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 Germany. 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?
Initial successful puncture of the common femoral artery (time frame: 1 week). 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 NCT06065943, 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 15 Aug 2024.