Type A Aortic DissectionCHINANCT03369977
BioGlue as an Adjunct for Structural Repair and Hemostasis in Chinese Acute Type A Aortic Dissections Patients
A study testing BioGlue Surgical Adhesive and Traditional Surgical Repair in people with Type A Aortic Dissection, run by CryoLife, Inc. at 7 sites in China.
Trial summary
A multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of BioGlue as an adjunct for structural repair and hemostasis to traditional surgical repair in Chinese subject with Acute type A aortic dissections. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type A Aortic Dissection
- What is being tested?
- BioGlue Surgical Adhesive and Traditional Surgical Repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 7 sitesChina
- Study dates
- 1 Nov 2017to Nov 2020
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18-70 years of age.
- Subject has a confirmed diagnosis of acute type A aortic dissection with subtype A2.
- Subject is willing and able to give written consent for the trial. If the subject is unconscious or under the influence of medications which render him or her unable to give fully informed consent, a guardian may provide informed consent for the subject regarding trial participation.
Who cannot join
- Subjects with known allergy to albumin, bovine products, or glutaraldehyde.
- Subjects who have been treated with an investigational product who have not completed the entire follow-up period.
- Subjects who do not meet the eligibility criteria, including those who do not wish to participate or give informed consent for trial participation, will not be enrolled into the trial, and will be offered equivalent, non-trial surgical or other treatment, as judged appropriate by the investigator.
- Subjects with previous cardiac and aortic surgery.
- End stage malperfusion syndromes (i.e. end-organ failure such as coma, paraplegia, hemiplegia, intestinal necrosis, or hepatic failure).
- Subjects with Marfan syndrome or other connective tissue disorders.
- Previous chronic dissections resulting from non-cardiac surgery and/or trauma.
- Concomitant surgery of valve replacement (both in screening and intraoperative).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing
Nanjing First Hospital
Nanjing
Changhai Hospital,The Second Military Medical University
Shanghai
Zhongshan Hospital, Fudan University
Shanghai
Wuhan Asia Heart Hospital
Wuhan
Henan Provincial People's Hospital
Zhengzhou
About this study
Official title: Multi-center, Randomized, Controlled Clinical Trial of BioGlue Surgical Adhesive as an Adjunct for Structural Repair and Hemostasis in Chinese Patients With Acute Type A Aortic Dissections.
A multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of BioGlue as an adjunct for structural repair and hemostasis to traditional surgical repair in Chinese subject with Acute type A aortic dissections.
Read the detailed description
A multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of BioGlue as an adjunct for structural repair and hemostasis in Chinese subjects with acute type A aortic dissection. The trial consists of three phases:
Phase One - A non-randomized, lead-in phase. During the lead-in phase, the first 2-3 eligible subjects at each center will receive BioGlue in open surgery. These subjects will be evaluated for safety separately from the randomized phase of the trial.
Phase Two - A randomized, controlled phase. Type A aortic dissection subjects will be randomized into TSR group (control group) and surgical repair with BioGlue group (test group) with a ratio of 1:1, so that equal number of subjects in test and control groups can be ensured.
Phase Three - A Follow-up of Late Safety Outcomes of using BioGlue in "The CHINA Trial" . Subjects enrolled in "The CHINA Trial," from both the BioGlue and the control (TSR) group, will be invited to participate. Clinical data evaluating mortality, adverse events, and re-operation rates will be collected from subject's medical charts.
- Conditions
- Type A Aortic Dissection
- Being tested
- BioGlue Surgical Adhesive, Traditional Surgical Repair
- Keywords
- BioGlue Surgical Adhesive, Type A Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioGlue Surgical AdhesiveDevice
BioGlue (produced by CryoLife in Kennesaw, GA) is a surgical adhesive with two components respectively purified bovine serum albumin (BSA) and Glutaraldehyde (their proportions are 4:1). Crosslinked bonds (covalent bonds) of Glutaraldehyde cross-link the protein on the surface of the tissue and the amino residue of the bovine serum albumin. BioGlue also adheres to the synthetic matrix material by a mechanical interlocking mechanism in the space of graft matrix.
Traditional Surgical RepairOther
Traditional surgical repair as determined by the surgeon
| Study group | Role | What they receive |
|---|---|---|
| BioGlue Surgical Adhesive | Experimental | Subjects in the BioGlue group will receive BioGlue as an adjunct for traditional surgical repair of the sinus of Valsalva. Receives: Device: BioGlue Surgical Adhesive |
| Traditional Surgical Repair | Other | Subjects in the control group will receive traditional surgical repair of the sinus of Valsalva. Receives: Other: Traditional Surgical Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Closure of the False Lumen
Successful closure of the false lumen as determined by intraoperative TEE. With successful closure of the false lumen, a complete disappearance of the false lumen will be achieved.
Measured: This success can be visually confirmed intraoperatively with a TEE (binary yes/no expression for each subject)
Secondary outcomes (5)
Successful closure of the false lumen by CTA or TTE at discharge
Successful closure of the false lumen at discharge or at 20 days (+/- 10 days) post-operatively confirmed by CTA scan or Transthoracic Echocardiogram (TTE) scan if the subject is unable to have a CTA.
Measured: CTA or TTE scan at discharge or at 20 days (+/- 10 days) post-operatively for subjects with longer hospital stays.
Time to repair the sinuses of Valsalva
During the operation the time to repair the sinuses of Valsalva will be recorded.
Measured: The time for repairing the sinuses of Valsalva will be documented intraoperatively.
Evaluate the successful hemostasis at the anastomotic site
Hemostasis is assessed visually (i.e. lack of any observable extravascular bleeding) and is monitored until hemostasis is achieved at each applied anastomotic site.
Measured: The measurement begins intraoperatively after either BioGlue or Traditional Surgical Repair is applied to the anastomotic suture line(s) and the bypass cross clamp is released.
Treatment failure of the aortic dissection repair site identified in "The CHINA Trial" which leads to either post-discharge mortality or re-operation.
Post-operative mortality and re-operation(s) will be collected from the subjects' medical charts retrospectively and during informed consent telephone notification.
Measured: The measurement begins at discharge and will end when the retrospective chart review is performed by the hospital (could be up to 3 years post-op)
Proportion of subjects with device-related or procedure-related adverse events, determined by the investigators.
Post-operative adverse event(s) will be collected from the subjects' medical charts retrospectively. Assessment will only be performed on the surgical site from "The CHINA Trial," defined as obliteration of the false lumen (BioGlue group) or repair of acute type A aortic dissection (control group) and anastomosis (both BioGlue and control groups).
Measured: The measurement begins at discharge and will end when the retrospective chart review is performed by the hospital (could be up to 3 years post-op).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start1 Nov 2017
- Primary completion24 Jun 2018
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type A Aortic DissectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- CryoLife, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott B Capps, MS, Study director, CryoLife, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369977
- Sponsor's protocol ID
- BIO1601.000-C(10/16)
- Acronym
- CHINA
- Status last verified
- May 2020
- First submitted
- 30 Nov 2017
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Controlled Clinical Trial of BioGlue Surgical Adhesive as an Adjunct for Structural Repair and Hemostasis in Chinese Patients With Acute Type A Aortic Dissections.
- ClinicalTrials.gov ID
- NCT03369977
- Acronym / sponsor ID
- CHINA / BIO1601.000-C(10/16)
- Conditions
- Type A Aortic Dissection
- Keywords
- BioGlue Surgical Adhesive, Type A Aortic Dissection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 202 participants (actual)
- Lead sponsor
- CryoLife, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 24 Jun 2018 (actual)
- Study completion
- Nov 2020 (estimated)
- First posted
- 12 Dec 2017 (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.
A multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of BioGlue as an adjunct for structural repair and hemostasis to traditional surgical repair in Chinese subject with Acute type A aortic dissections.
Detailed description
A multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of BioGlue as an adjunct for structural repair and hemostasis in Chinese subjects with acute type A aortic dissection. The trial consists of three phases:
Phase One - A non-randomized, lead-in phase. During the lead-in phase, the first 2-3 eligible subjects at each center will receive BioGlue in open surgery. These subjects will be evaluated for safety separately from the randomized phase of the trial.
Phase Two - A randomized, controlled phase. Type A aortic dissection subjects will be randomized into TSR group (control group) and surgical repair with BioGlue group (test group) with a ratio of 1:1, so that equal number of subjects in test and control groups can be ensured.
Phase Three - A Follow-up of Late Safety Outcomes of using BioGlue in "The CHINA Trial" . Subjects enrolled in "The CHINA Trial," from both the BioGlue and the control (TSR) group, will be invited to participate. Clinical data evaluating mortality, adverse events, and re-operation rates will be collected from subject's medical charts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioGlue Surgical Adhesive | Experimental | Device: BioGlue Surgical AdhesiveSubjects in the BioGlue group will receive BioGlue as an adjunct for traditional surgical repair of the sinus of Valsalva. |
| Traditional Surgical Repair | Other | Other: Traditional Surgical RepairSubjects in the control group will receive traditional surgical repair of the sinus of Valsalva. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects 18-70 years of age.
- Subject has a confirmed diagnosis of acute type A aortic dissection with subtype A2.
- Subject is willing and able to give written consent for the trial. If the subject is unconscious or under the influence of medications which render him or her unable to give fully informed consent, a guardian may provide informed consent for the subject regarding trial participation.
Key exclusion criteria (8 listed)
- Subjects with known allergy to albumin, bovine products, or glutaraldehyde.
- Subjects who have been treated with an investigational product who have not completed the entire follow-up period.
- Subjects who do not meet the eligibility criteria, including those who do not wish to participate or give informed consent for trial participation, will not be enrolled into the trial, and will be offered equivalent, non-trial surgical or other treatment, as judged appropriate by the investigator.
- Subjects with previous cardiac and aortic surgery.
- End stage malperfusion syndromes (i.e. end-organ failure such as coma, paraplegia, hemiplegia, intestinal necrosis, or hepatic failure).
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 |
|---|---|---|
| BioGlue Surgical AdhesiveBioGlue (produced by CryoLife in Kennesaw, GA) is a surgical adhesive with two components respectively purified bovine serum albumin (BSA) and Glutaraldehyde (their proportions are 4:1). Crosslinked bonds (covalent bonds) of Glutaraldehyde cross-link the protein on the surface of the tissue and the amino residue of the bovine serum albumin. BioGlue also adheres to the synthetic matrix material by a mechanical interlocking mechanism in the space of graft matrix. | Device | BioGlue Surgical Adhesive |
| Traditional Surgical RepairTraditional surgical repair as determined by the surgeon | Other | Traditional Surgical Repair |
Primary outcome
Successful Closure of the False Lumen
Time frame: This success can be visually confirmed intraoperatively with a TEE (binary yes/no expression for each subject)
Successful closure of the false lumen as determined by intraoperative TEE. With successful closure of the false lumen, a complete disappearance of the false lumen will be achieved.
5 secondary outcomes
Successful closure of the false lumen by CTA or TTE at discharge
Time frame: CTA or TTE scan at discharge or at 20 days (+/- 10 days) post-operatively for subjects with longer hospital stays.
Time to repair the sinuses of Valsalva
Time frame: The time for repairing the sinuses of Valsalva will be documented intraoperatively.
Evaluate the successful hemostasis at the anastomotic site
Time frame: The measurement begins intraoperatively after either BioGlue or Traditional Surgical Repair is applied to the anastomotic suture line(s) and the bypass cross clamp is released.
Treatment failure of the aortic dissection repair site identified in "The CHINA Trial" which leads to either post-discharge mortality or re-operation.
Time frame: The measurement begins at discharge and will end when the retrospective chart review is performed by the hospital (could be up to 3 years post-op)
Proportion of subjects with device-related or procedure-related adverse events, determined by the investigators.
Time frame: The measurement begins at discharge and will end when the retrospective chart review is performed by the hospital (could be up to 3 years post-op).
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 19 May 2020.
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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.
Scott B Capps, MS study director
CryoLife, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioGlue Surgical Adhesive and Traditional Surgical Repair in people with Type A Aortic Dissection, run by CryoLife, Inc. at 7 sites in China.
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 8 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 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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?
Successful Closure of the False Lumen (time frame: This success can be visually confirmed intraoperatively with a TEE (binary yes/no expression for each subject)). 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 19 May 2020.