Aortic DissectionPROTECTNCT03894033
Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection
An observational study of Aortic Dissection and Acute DeBakey I Dissection, run by JOTEC GmbH at 1 site in Germany.
Trial summary
The objective of this registry is to collect information on the performance and clinical benefits of the AMDS (Ascyrus Medical Dissection Stent) to treat patients with acute "DeBakey type I dissections" and with or without so called "preoperative clinically relevant malperfusion" and/or "intramural hematomas". Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Dissection, Acute DeBakey I Dissection, Acute Type A Dissection
- What is being tested?
- Ascyrus Medical Dissection Stent (AMDS)
- Type of treatment
- Medical device
- How many people
- 301 participants
- Where
- 1 siteGermany
- Study dates
- 12 Mar 2019to 30 Jun 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with Acute DeBakey type I dissection based on CT angiography or IMH based on CT angiography and treated with the AMDS.
Who may be able to join
- ≥18 and ≤ 80 years of age (male or female)
- One of the following diagnosed within 14 days:
- Acute DeBakey type I dissection based on CT angiography; or
- IMH based on CT angiography
Who cannot join
- General Exclusion Criteria:
- < 18 years of age or > 80 years of age (male or female)
- Unwilling to comply with the follow-up schedule
- Refusal to give Informed Consent
- Medical Exclusion Criteria:
- Uncontrolled systemic infection
Show all 16Show fewer
- Uncontrollable anaphylaxis to iodinated contrast
- Known allergy(ies) to nitinol and/ or PTFE
- Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR)
- Preoperative coma
- Anatomical Exclusion Criteria:
- Any pathology of mycotic origin
- Subacute or chronic dissection of the ascending aorta and aortic arch (>14 days after the index event)
- Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
- Extensive thrombus or calcification in the aortic arch as defined by CT angiography
- Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography
Trial locations and contacts
1 site in 1 country.
Germany1 site
Deutsches Herzzentrum der Charité
Berlin, State of Berlin, 13353
About this study
Official title: Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection: PROTECT Registry
The objective of this registry is to collect information on the performance and clinical benefits of the AMDS (Ascyrus Medical Dissection Stent) to treat patients with acute "DeBakey type I dissections" and with or without so called "preoperative clinically relevant malperfusion" and/or "intramural hematomas".
In a healthy aorta (the vessel that supplies blood to most of the body) the blood flows freely through the main lumen (a space inside the vessel where blood flows). The participants involved in this study have a tear that has separated the inner layer of the aorta wall and created a secondary channel (false lumen) in addition to the main channel (true lumen), and huts, the blood flows through both channels.
AMDS is a stent (a metal tube helping to keep the vessel open) that is placed in the descending thoracic aorta. AMDS is a medical device commercially available in the countries in which the study is being conducted and it is used as standard of care according to its indication.
Read the detailed description
Observational, prospective and retrospective, non-randomized, non-interventional study to investigate the performance and clinical benefits of the AMDS to treat patients with acute DeBakey type I dissections with or without clinically relevant preoperative malperfusion and/or intramural hematomas (IMH).
Participating physicians will be asked to provide their observations collected during routine care for patients they had decided to treat with AMDS. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected.
A total number of 300 subjects will be enrolled in up to 30 sites in Europe and Canada. The AMDS will be implanted according to the instructions for use and at the discretion of the treating physician.
This registry was initiated by Ascyrus Medical GmbH in August 2019 (DARTS PM Registry). About 70 patients were enrolled at that time by German and Canadian sites under previous protocol. The patient's enrollment was put on-hold and the study has been re-started as PROTECT Registry with updated study documents as per JOTEC's standard operating procedures upon Ethics Committees approvals.
Patients already included in DARTS PM Registry will be re-consented (where applicable as per local regulatory requirements) to allow the retrospective and prospective collection of additional data points not included in the initial version of the protocol. It is also planned to retrospectively include up to 150 subjects of the 300 targeted subjects, which have been treated with AMDS and who consent to the collection of their data (if required by national law) and are willing to continue in this registry, if applicable.
- Conditions
- Aortic Dissection, Acute DeBakey I Dissection, Acute Type A Dissection, Intramural Hematoma
- Being tested
- Ascyrus Medical Dissection Stent (AMDS)
- Keywords
- Aortic diseases, Cardiovascular diseases, Aortic Dissection, Aortic Remodeling, Malperfusion, Acute Aortic Dissection
- Medical subject headings
- Aortic Dissection, Aortic Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascyrus Medical Dissection Stent (AMDS)Device
Also called AMDS Arch Remodeling Therapy
The device will be implanted during already planned surgical intervention for aortic dissection repair. The participant will be observed and data gathered during the surgery and routine standard of care follow up visits.
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive arch remodeling
Rate of patients with positive arch remodeling defined as either stable or decreasing total aortic diameter in zone 2.
Measured: 3-6 months
Secondary outcomes (29)
All-cause mortality
Rate of all-cause mortality
Measured: In-hospital, at 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years
Device-related in-hospital mortality
Rate of device-related in-hospital mortality
Measured: Discharge (definition: between 1-29 days)
Device-related mortality
Rate of device-related mortality
Measured: 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years
Resolution of malperfusion in patients who presented initially with malperfusion
Rate of patients with resolution of malperfusion in patients who presented initially with malperfusion
Measured: Discharge (definition: between 1-29 days), 30 days, and 3-6 months
New disabling (Modified Rankin Scale mRS ≥ 2), permanent (>30 days) stroke
Rate of patients with new disabling (mRS ≥ 2), permanent (>30 days) stroke
Measured: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
New disabling (Modified Rankin Scale mRS ≥ 2), transient (< 30 days) stroke
Rate of patients with new disabling (mRS ≥ 2), transient (< 30 days) stroke
Measured: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
New paralysis
Rate of patients with new paralysis
Measured: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
New paraplegia
Rate of patients with new paraplegia and 5 years
Measured: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
New aortic rupture associated with the implantation of the device
Rate of patients with new aortic rupture associated with the implantation of the device (procedure or AMDS related)
Measured: 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
Patent innominate artery
Rate of patients with patent innominate artery (< 50% stenosis of the origin of the branch vessels)
Measured: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
Source of innominate artery stenosis
Source of innominate artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel)
Measured: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Patent left carotid artery
Rate of patients with patent left carotid artery (< 50% stenosis of the origin of the branch vessels)
Measured: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
Source of left carotid artery stenosis
Source of left carotid artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel)
Measured: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
Patent left subclavian artery
Rate of patients with patent left subclavian artery (< 50% stenosis of the origin of the branch vessels)
Measured: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
Source of left subclavian artery stenosis
Source of left subclavian artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel)
Measured: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Absence of distal anastomotic new entry tear (DANE)
Rate of patients with absence of distal anastomotic new entry tear (DANE)
Measured: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)
Increasing true lumen
Rate of patients with increasing true lumen [change in diameter at the maximal diameter location within each Zone which is greater than or equal to a 5 mm expansion in comparison to the diameter on the pre-op computed tomography angiography (CTA) scan] in the stented region (Zones 1-3)
Measured: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)
Stable true lumen
Rate of patients with stable true lumen [change in diameter at the maximal diameter location within each Zone which is between a 5 mm reduction and a 5 mm expansion in comparison to the diameter on the pre-op computed tomography angiography (CTA) scan] in the stented region (Zones 1-3)
Measured: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)
Stable or increasing true lumen in the stented region
Rate of patients with stable or increasing true lumen in the stented region (Zones 1-3)
Measured: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Decreasing true lumen
Rate of patients with decreasing true lumen [change in diameter at the maximal diameter location within each Zone which is greater than or equal to a 5 mm reduction in comparison to the diameter on the pre-op computed tomography angiography (CTA) scan] in the stented region (Zones 1-3)
Measured: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Increasing false lumen
Rate of patients with increasing false lumen (≥ 5mm) in the stented region (Zones 1-3)
Measured: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Stable false lumen in the stented region
Rate of patients with stable false lumen in the stented region (Zones 1-3)
Measured: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Decreasing false lumen
Rate of patients with decreasing false lumen (≤ - 5 mm) in the stented region (Zones 1-3)
Measured: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Rate of patients with stable or decreasing false lumen
Stable or decreasing false lumen in the stented region (Zones 1-3)
Measured: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Freedom from AMDS stent removal
Rate of patients with freedom from AMDS stent removal
Measured: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
Freedom from AMDS-related reintervention
Rate of patients with freedom from AMDS-related reintervention
Measured: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
Freedom from aortic arch reintervention
Rate of patients with freedom from aortic arch reintervention
Measured: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
Successful AMDS deployment (at discharge
Rate of patients with successful AMDS deployment (at discharge
Measured: Discharge (definition: between 1-29 days)
Completely thrombosed, partially thrombosed, or patent false lumen in the arch and descending aorta (Zones 0-5)
Rate of patients with completely thrombosed, partially thrombosed, or patent false lumen in the arch and descending aorta (Zones 0-5)
Measured: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start12 Mar 2019
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by JOTEC GmbHThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 301 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jörg Kempfert, Prof., Principal investigator, Deutsches Herzzentrum der Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894033
- Sponsor's protocol ID
- PROTECT Registry
- Acronym
- PROTECT
- Status last verified
- Feb 2026
- First submitted
- 27 Mar 2019
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All study participant data will be de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection: PROTECT Registry
- ClinicalTrials.gov ID
- NCT03894033
- Acronym / sponsor ID
- PROTECT / PROTECT Registry
- Conditions
- Aortic Dissection, Acute DeBakey I Dissection, Acute Type A Dissection, Intramural Hematoma
- Keywords
- Aortic diseases, Cardiovascular diseases, Aortic Dissection, Aortic Remodeling, Malperfusion, Acute Aortic Dissection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 301 participants (actual)
- Lead sponsor
- JOTEC GmbHIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 28 Mar 2019 (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 objective of this registry is to collect information on the performance and clinical benefits of the AMDS (Ascyrus Medical Dissection Stent) to treat patients with acute "DeBakey type I dissections" and with or without so called "preoperative clinically relevant malperfusion" and/or "intramural hematomas".
In a healthy aorta (the vessel that supplies blood to most of the body) the blood flows freely through the main lumen (a space inside the vessel where blood flows). The participants involved in this study have a tear that has separated the inner layer of the aorta wall and created a secondary channel (false lumen) in addition to the main channel (true lumen), and huts, the blood flows through both channels.
AMDS is a stent (a metal tube helping to keep the vessel open) that is placed in the descending thoracic aorta. AMDS is a medical device commercially available in the countries in which the study is being conducted and it is used as standard of care according to its indication.
Detailed description
Observational, prospective and retrospective, non-randomized, non-interventional study to investigate the performance and clinical benefits of the AMDS to treat patients with acute DeBakey type I dissections with or without clinically relevant preoperative malperfusion and/or intramural hematomas (IMH).
Participating physicians will be asked to provide their observations collected during routine care for patients they had decided to treat with AMDS. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected.
A total number of 300 subjects will be enrolled in up to 30 sites in Europe and Canada. The AMDS will be implanted according to the instructions for use and at the discretion of the treating physician.
This registry was initiated by Ascyrus Medical GmbH in August 2019 (DARTS PM Registry). About 70 patients were enrolled at that time by German and Canadian sites under previous protocol. The patient's enrollment was put on-hold and the study has been re-started as PROTECT Registry with updated study documents as per JOTEC's standard operating procedures upon Ethics Committees approvals.
Patients already included in DARTS PM Registry will be re-consented (where applicable as per local regulatory requirements) to allow the retrospective and prospective collection of additional data points not included in the initial version of the protocol. It is also planned to retrospectively include up to 150 subjects of the 300 targeted subjects, which have been treated with AMDS and who consent to the collection of their data (if required by national law) and are willing to continue in this registry, if applicable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with Acute DeBakey type I dissection based on CT angiography or IMH based on CT angiography and treated with the AMDS.
Key inclusion criteria (4 listed)
- ≥18 and ≤ 80 years of age (male or female)
- One of the following diagnosed within 14 days:
Key exclusion criteria (16 listed)
- < 18 years of age or > 80 years of age (male or female)
- Unwilling to comply with the follow-up schedule
- Refusal to give Informed Consent
- Uncontrolled systemic infection
- Uncontrollable anaphylaxis to iodinated contrast
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 |
|---|---|---|
| Ascyrus Medical Dissection Stent (AMDS)Also: AMDS Arch Remodeling TherapyThe device will be implanted during already planned surgical intervention for aortic dissection repair. The participant will be observed and data gathered during the surgery and routine standard of care follow up visits. | Device | – |
Primary outcome
Positive arch remodeling
Time frame: 3-6 months
Rate of patients with positive arch remodeling defined as either stable or decreasing total aortic diameter in zone 2.
29 secondary outcomes
All-cause mortality
Time frame: In-hospital, at 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years
Device-related in-hospital mortality
Time frame: Discharge (definition: between 1-29 days)
Device-related mortality
Time frame: 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years
Resolution of malperfusion in patients who presented initially with malperfusion
Time frame: Discharge (definition: between 1-29 days), 30 days, and 3-6 months
New disabling (Modified Rankin Scale mRS ≥ 2), permanent (>30 days) stroke
Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
New disabling (Modified Rankin Scale mRS ≥ 2), transient (< 30 days) stroke
Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
New paralysis
Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
New paraplegia
Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
New aortic rupture associated with the implantation of the device
Time frame: 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
Patent innominate artery
Time frame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
Source of innominate artery stenosis
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Patent left carotid artery
Time frame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
Source of left carotid artery stenosis
Time frame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
Patent left subclavian artery
Time frame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
Source of left subclavian artery stenosis
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Absence of distal anastomotic new entry tear (DANE)
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)
Increasing true lumen
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)
Stable true lumen
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)
Stable or increasing true lumen in the stented region
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Decreasing true lumen
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Increasing false lumen
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Stable false lumen in the stented region
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Decreasing false lumen
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Rate of patients with stable or decreasing false lumen
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Freedom from AMDS stent removal
Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
Freedom from AMDS-related reintervention
Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
Freedom from aortic arch reintervention
Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
Successful AMDS deployment (at discharge
Time frame: Discharge (definition: between 1-29 days)
Completely thrombosed, partially thrombosed, or patent false lumen in the arch and descending aorta (Zones 0-5)
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No. All study participant data will be de-identified.
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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.
Jörg Kempfert, Prof. principal investigator
Deutsches Herzzentrum der Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection and Acute DeBakey I Dissection, run by JOTEC GmbH 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 4 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 9 Feb 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Positive arch remodeling (time frame: 3-6 months). 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 9 Feb 2026.