Aortic DissectionNCT05996354

Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases

A study testing Concave Supra-arch Branched stent-graft system in people with Aortic Dissection and Aneurysm, Aortic Arch, run by China National Center for Cardiovascular Diseases at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

There are no endoluminal stent systems available on the Chinese market for the effective treatment of aortic arch lesions (involving aortic arch aneurysms, aortic coarctation, aortic pseudoaneurysms, aortic ulcers, and intermural hematomas), and therefore this study is intended to be a prospective, single-arm study. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Aortic Dissection, Aneurysm, Aortic Arch, Aortic Pseudoaneurysm
What is being tested?: Concave Supra-arch Branched stent-graft system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 3 sitesChina
Study dates: 1 Mar 2022to 30 Apr 2025
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 who are ≥ 18 years old and ≤ 85 years old；
Patients with aortic arch diseases (involving aortic arch aneurysm, aortic dissection, aortic pseudoaneurysm, aortic ulcer, and intermural hematoma);
Anatomical criteria, including:
Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);
The diameter range of the anchoring area at the proximal end of the main body is between 25-45 mm and the length is greater than or equal to 15 mm;
The diameter of the anchored area of the innominate artery is between 10-16 mm, the diameter of the anchored area of the left common carotid artery is between 5-12 mm, and the diameter of the anchored area of the left subclavian artery is between 5-12 mm. Anchorage zone length is greater than or equal to 15 mm;

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Distance between the anterior edge of the innominate artery to the posterior edge of the left subclavian artery is less than or equal to 80 mm;
Have a suitable iliac, femoral, and superior arch arterial approach;
Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up visits as required by the protocol.

Who cannot join

Patients with general or local infections that may increase the risk of endovascular graft infection;
Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to make the stent-graft difficult to adhere to or affect the patency of the stent;
Patients with neck vascular surgery within 3 months;
Patients with severe carotid or subclavian artery stenosis, calcification;
Patients with a history of acute coronary syndrome within 6 months:
Acute coronary syndromes are cardiac acute ischemic syndromes resulting from rupture of an unstable atherosclerotic plaque in the coronary artery or erosion secondary to the formation of new blood 4 thrombus, including ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina.

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Patients with transient ischemic attack (TIA) or ischemic stroke within 3 months;
Patients with preoperative hepatic and renal dysfunction, [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeded the upper limit of normal level by a factor of five; Serum creatinine (Cr) >150umol/L];
Patients with history of bleeding or coagulopathy, who cannot receive antiplatelet therapy;
Patients with severe aortic insufficiency or a history of prior aortic valve insufficiency treatment;
Patients with a history of hypersensitivity to contrast agents, anticoagulant antiplatelet agents, stents, delivery equipment materials (i.e., nitinol, polyester, PTFE, nylon polymer materials);
Patients with connective tissue diseases such as Marfan's syndrome, Egyptian syndrome, or Behcet's disease;
Patients with arteritis;
Patients with significant organ dysfunction or other serious disease;
Patients with life expectancy of not more than 1 year;
Patients who are not eligible for endovascular treatment per in the investigator's judgment of the investigator;
Women with planned pregnancy, pregnancy stage , or lactation
The patient participated in another clinical trial and was not out or withdrawn within the first 3 months of the screening period of this study.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Chinese Academy of Medical Sciences Fuwai Hospital
Beijing, Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Yunnan Fuwai cardiovascular disease Hospital
YunNan, Yunnan

Other trials in China

About this study

Official title: A Study on the Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases

Read the detailed description

The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs to be eliminated immediately, it may be reported in written form afterwards. During the course of the study, documents such as amendments to the clinical study protocol and informed consent, requests for deviation, and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee.

Conditions: Aortic Dissection, Aneurysm, Aortic Arch, Aortic Pseudoaneurysm, Aortic Ulcer, Penetrating, Aortic Intramural Hematoma
Being tested: Concave Supra-arch Branched stent-graft system
Medical subject headings: Aortic Dissection, Aneurysm, Aortic Arch, Penetrating Atherosclerotic Ulcer, Aortic Intramural Hematoma

What participants receive

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

Concave Supra-arch Branched stent-graft systemDevice
To evaluate the efficacy and safety of the Concave Supra-arch Branched stent-graft system for endovascular treatment of aortic arch diseases.

Study groups in NCT05996354
Study group	Role	What they receive
Intervention arm	Experimental	Concave Supra-arch Branched stent-graft system Receives: Device: Concave Supra-arch Branched stent-graft system

What is being measured

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

Immediate technical success rate
Immediate technical success refers to the successful delivery system to a predetermined location, the successful deployment of the system and the safe withdrawal of the delivery system from the body, and the branch arteries were successfully reconstructed.
Measured: Immediate intraoperative

Timeline

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

1 Mar 202230 Apr 2025

First posted18 Aug 2023
Study start1 Mar 2022
Primary completion1 Oct 2023 (estimated)
Study completion30 Apr 2025 (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 China National Center for Cardiovascular DiseasesThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05996354
Sponsor's protocol ID: XJ-PR48-FIM-05
Status last verified: Oct 2023
First submitted: 3 Aug 2023
Last updated: 11 Oct 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Aortic Dissection trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study on the Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases
ClinicalTrials.gov ID: NCT05996354
Acronym / sponsor ID: XJ-PR48-FIM-05
Conditions: Aortic Dissection, Aneurysm, Aortic Arch, Aortic Pseudoaneurysm, Aortic Ulcer, Penetrating, Aortic Intramural Hematoma
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 10 participants (actual)
Lead sponsor: China National Center for Cardiovascular DiseasesOther government
Study start: 1 Mar 2022 (actual)
Primary completion: 1 Oct 2023 (estimated)
Study completion: 30 Apr 2025 (estimated)
First posted: 18 Aug 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention arm	Experimental	Device: Concave Supra-arch Branched stent-graft systemConcave Supra-arch Branched stent-graft system

Who may qualify

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

Key inclusion criteria (9 listed)

Patients who are ≥ 18 years old and ≤ 85 years old；
Patients with aortic arch diseases (involving aortic arch aneurysm, aortic dissection, aortic pseudoaneurysm, aortic ulcer, and intermural hematoma);
Anatomical criteria, including:
Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up visits as required by the protocol.

Key exclusion criteria (18 listed)

Patients with general or local infections that may increase the risk of endovascular graft infection;
Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to make the stent-graft difficult to adhere to or affect the patency of the stent;
Patients with neck vascular surgery within 3 months;
Patients with severe carotid or subclavian artery stenosis, calcification;
Patients with a history of acute coronary syndrome within 6 months:

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
Concave Supra-arch Branched stent-graft systemTo evaluate the efficacy and safety of the Concave Supra-arch Branched stent-graft system for endovascular treatment of aortic arch diseases.	Device	Intervention arm

Primary outcome

Immediate technical success rate
Time frame: Immediate intraoperative
Immediate technical success refers to the successful delivery system to a predetermined location, the successful deployment of the system and the safe withdrawal of the delivery system from the body, and the branch arteries were successfully reconstructed.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
Individual participant dataSharing planned: No

Related trials for Aortic Dissection

Not yet recruitingPhase 2
D2 Gastrectomy With or Without Para-Aortic Lymph Node Dissection After Chemoimmunotherapy for Gastric Cancer
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Not yet recruitingObservational study
Clinical Health Outcomes Evaluation of Terumo Aortic Hybrid Devices
Aortic Aneurysm and Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingObservational study
Metabolic Phenotyping in vEDS
Vascular Ehlers-Danlos Syndrome, Vascular Ehlers Danlos Syndrome
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
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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.

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

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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?

Results are not available in the source record.

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?

Immediate technical success rate (time frame: Immediate intraoperative). 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 NCT05996354.

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 11 Oct 2023.