Coronary Artery DiseasePhase 4ISAR-CLOSURENCT01389375
Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial
A Phase 4 study testing FemoSeal®, ExoSeal® and Manual compression in people with Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
Trial summary
Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography? Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- FemoSeal®, ExoSeal® and Manual compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,524 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2011to Jul 2014
- Phase
- Phase 4
- 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
- Patient between 18 and 85 years of age
- Patients undergoing femoral access coronary angiography
- Access only with 6 F sheath
- Patient must be competent for providing informed written consent
Who cannot join
- Peripheral arterial occlusive disease
- Prior peripheral artery surgery
- Percutaneous coronary intervention
- Femoral access device closure in last 30 days
- Scheduled Coronary Angiography/Intervention within 90 days
- Critical limb ischemic
Show all 13Show fewer
- Uncontrolled hypertension >220/110 mmHg
- Coagulopathy (bleeding disorder)
- Local infection
- Common femoral artery lumen diameter < 5 mm
- Allergy to absorbable suture
- Autoimmune Disease
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Deutsches Herzzentrum Muenchen
Munich, 80636
Klinikum rechts der Isar
Munich, 81675
About this study
Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?
Read the detailed description
Vascular closure devices have been shown to be safe and effective in reducing the time to hemostasis and immobilization when compared to manual compression following coronary angiography. This effect is beneficial in patients presenting with chronic back pain, prostate enlargement, mental impairment or other disorders that preclude prolonged bed rest.
However, adequately powered large scale randomized trials with vascular closure devices remain a gap in the scientific literature.
This trial compares, in a randomised design two novel vascular closure devices (FemoSeal \& ExoSeal) versus manual compression after coronary angiography. This study is aimed to investigate if novel vascular closure devices are noninferior to manual compression regarding access site complications.
- Conditions
- Coronary Artery Disease
- Being tested
- FemoSeal®, ExoSeal®, Manual compression
- Keywords
- Closure Device, Coronary Angiography
- 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.
FemoSeal®Device
Closure device for femoral artery access closure
ExoSeal®Device
Closure device for femoral artery access closure
Manual compressionOther
Conventional manual compression
| Study group | Role | What they receive |
|---|---|---|
| FemoSeal® | Experimental | Device: FemoSeal® Receives: Device: FemoSeal® |
| ExoSeal® | Experimental | Device: ExoSeal® Receives: Device: ExoSeal® |
| Manual compression | Active comparator | Other: Manual compression Receives: Other: Manual compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of arterial access related complications
Composite of arterial access related complications, defined as the composite of:
- Rate of ipsilateral groin hematomas with largest diameter exceeding 5 cm
- Pseudoaneurysm
- AV-Fistula
- Major bleeding
- Critical limb ischemia
- Local infection
- Surgical repair
- Revascularisation
Measured: 30 days
Secondary outcomes (4)
Time to hemostasis, from sheath removal to complete hemostasis
Measured: 30 days
Device deployment failure
Measured: 30 days
Need for repeated manual compression after end of closure procedure
Measured: 30 days
Cost-benefit Analysis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Linhardt, MD, Principal investigator, Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389375
- Sponsor's protocol ID
- GE IDE No. PCD00111
- Acronym
- ISAR-CLOSURE
- Status last verified
- Jul 2014
- First submitted
- 5 Jul 2011
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Schulz-Schupke S, Helde S, Gewalt S, Ibrahim T, Linhardt M, Haas K, Hoppe K, Bottiger C, Groha P, Bradaric C, Schmidt R, Bott-Flugel L, Ott I, Goedel J, Byrne RA, Schneider S, Burgdorf C, Morath T, Kufner S, Joner M, Cassese S, Hoppmann P, Hengstenberg C, Pache J, Fusaro M, Massberg S, Mehilli J, Schunkert H, Laugwitz KL, Kastrati A; Instrumental Sealing of Arterial Puncture Site-CLOSURE Device vs Manual Compression (ISAR-CLOSURE) Trial Investigators. Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial. JAMA. 2014 Nov 19;312(19):1981-7. doi: 10.1001/jama.2014.15305.
PubMed 25399273Gewalt SM, Helde SM, Ibrahim T, Mayer K, Schmidt R, Bott-Flugel L, Hoppe K, Ott I, Hieber J, Morath T, Byrne RA, Kufner S, Cassese S, Hoppmann P, Fusaro M, Schunkert H, Laugwitz KL, Kastrati A, Schupke S; Instrumental Sealing of Arterial Puncture Site-CLOSURE Device Versus Manual Compression (ISAR-CLOSURE) Trial Investigators. Comparison of Vascular Closure Devices Versus Manual Compression After Femoral Artery Puncture in Women. Circ Cardiovasc Interv. 2018 Aug;11(8):e006074. doi: 10.1161/CIRCINTERVENTIONS.117.006074.
PubMed 30354782Xhepa E, Byrne RA, Schulz S, Helde S, Gewalt S, Cassese S, Linhardt M, Ibrahim T, Mehilli J, Hoppe K, Grupp K, Kufner S, Bottiger C, Hoppmann P, Burgdorf C, Fusaro M, Ott I, Schneider S, Hengstenberg C, Schunkert H, Laugwitz KL, Kastrati A; ISAR-CLOSURE investigators. Rationale and design of a randomised clinical trial comparing vascular closure device and manual compression to achieve haemostasis after diagnostic coronary angiography: the Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial. EuroIntervention. 2014 Jun;10(2):198-203. doi: 10.4244/EIJV10I2A33.
PubMed 24952057
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial
- ClinicalTrials.gov ID
- NCT01389375
- Acronym / sponsor ID
- ISAR-CLOSURE / GE IDE No. PCD00111
- Conditions
- Coronary Artery Disease
- Keywords
- Closure Device, Coronary Angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,524 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Jul 2011 (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.
Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?
Detailed description
Vascular closure devices have been shown to be safe and effective in reducing the time to hemostasis and immobilization when compared to manual compression following coronary angiography. This effect is beneficial in patients presenting with chronic back pain, prostate enlargement, mental impairment or other disorders that preclude prolonged bed rest.
However, adequately powered large scale randomized trials with vascular closure devices remain a gap in the scientific literature.
This trial compares, in a randomised design two novel vascular closure devices (FemoSeal \& ExoSeal) versus manual compression after coronary angiography. This study is aimed to investigate if novel vascular closure devices are noninferior to manual compression regarding access site complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FemoSeal® | Experimental | Device: FemoSeal®Device: FemoSeal® |
| ExoSeal® | Experimental | Device: ExoSeal®Device: ExoSeal® |
| Manual compression | Active comparator | Other: Manual compressionOther: Manual compression |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient between 18 and 85 years of age
- Patients undergoing femoral access coronary angiography
- Access only with 6 F sheath
- Patient must be competent for providing informed written consent
Key exclusion criteria (13 listed)
- Peripheral arterial occlusive disease
- Prior peripheral artery surgery
- Percutaneous coronary intervention
- Femoral access device closure in last 30 days
- Scheduled Coronary Angiography/Intervention within 90 days
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 |
|---|---|---|
| FemoSeal®Closure device for femoral artery access closure | Device | FemoSeal® |
| ExoSeal®Closure device for femoral artery access closure | Device | ExoSeal® |
| Manual compressionConventional manual compression | Other | Manual compression |
Primary outcome
Composite of arterial access related complications
Time frame: 30 days
Composite of arterial access related complications, defined as the composite of: * Rate of ipsilateral groin hematomas with largest diameter exceeding 5 cm * Pseudoaneurysm * AV-Fistula * Major bleeding * Critical limb ischemia * Local infection * Surgical repair * Revascularisation
4 secondary outcomes
Time to hemostasis, from sheath removal to complete hemostasis
Time frame: 30 days
Device deployment failure
Time frame: 30 days
Need for repeated manual compression after end of closure procedure
Time frame: 30 days
Cost-benefit Analysis
Time frame: 30 days
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 10 Jun 2016.
- Background: PubMed 25399273Schulz-Schupke S, Helde S, Gewalt S, Ibrahim T, Linhardt M, Haas K, Hoppe K, Bottiger C, Groha P, Bradaric C, Schmidt R, Bott-Flugel L, Ott I, Goedel J, Byrne RA, Schneider S, Burgdorf C, Morath T, Kufner S, Joner M, Cassese S, Hoppmann P, Hengstenberg C, Pache J, Fusaro M, Massberg S, Mehilli J, Schunkert H, Laugwitz KL, Kastrati A; Instrumental Sealing of Arterial Puncture Site-CLOSURE Device vs Manual Compression (ISAR-CLOSURE) Trial Investigators. Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial. JAMA. 2014 Nov 19;312(19):1981-7. doi: 10.1001/jama.2014.15305.
- Derived from this study: PubMed 30354782Gewalt SM, Helde SM, Ibrahim T, Mayer K, Schmidt R, Bott-Flugel L, Hoppe K, Ott I, Hieber J, Morath T, Byrne RA, Kufner S, Cassese S, Hoppmann P, Fusaro M, Schunkert H, Laugwitz KL, Kastrati A, Schupke S; Instrumental Sealing of Arterial Puncture Site-CLOSURE Device Versus Manual Compression (ISAR-CLOSURE) Trial Investigators. Comparison of Vascular Closure Devices Versus Manual Compression After Femoral Artery Puncture in Women. Circ Cardiovasc Interv. 2018 Aug;11(8):e006074. doi: 10.1161/CIRCINTERVENTIONS.117.006074.
- Derived from this study: PubMed 24952057Xhepa E, Byrne RA, Schulz S, Helde S, Gewalt S, Cassese S, Linhardt M, Ibrahim T, Mehilli J, Hoppe K, Grupp K, Kufner S, Bottiger C, Hoppmann P, Burgdorf C, Fusaro M, Ott I, Schneider S, Hengstenberg C, Schunkert H, Laugwitz KL, Kastrati A; ISAR-CLOSURE investigators. Rationale and design of a randomised clinical trial comparing vascular closure device and manual compression to achieve haemostasis after diagnostic coronary angiography: the Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial. EuroIntervention. 2014 Jun;10(2):198-203. doi: 10.4244/EIJV10I2A33.
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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.
Maryam Linhardt, MD principal investigator
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FemoSeal®, ExoSeal® and Manual compression in people with Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 2 sites 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 4 inclusion and 13 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 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composite of arterial access related complications (time frame: 30 days). 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 NCT01389375, which also lists 3 linked publications.
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 10 Jun 2016.