Coronary In SentrestenosisNCT03624205
The Safety and Efficacy of SeQuent® Please in Real World Chinese Coronary Instent Restenosis Patients
An observational study of Coronary In Sentrestenosis, run by B. Braun Medical International Trading Company Ltd..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of paclitaxel -eluting PTCA- balloon (SeQuent® Please) in real world Chinese Coronary In Sentrestenosis patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary In Sentrestenosis
- What is being tested?
- paclitaxel-releasing coronary balloon (SeQuent® Please)
- Type of treatment
- Medical device
- How many people
- 520 participants
- Where
- No sites listed yet
- Study dates
- 24 Apr 2015to 1 Mar 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 80 years
- All sexes
- Adult, Older adult
Study population: patient with coronary In sentrestenosis
Who may be able to join
- Criteria related to subjects
- At the age of 18-80, Both male and female;
- Patients with coronary In sentrestenosis and suitable for the theory of Drug Eluting PTCA Balloon Catheter（SeQuent® Please）, no more than 1 target lesion in each coronary artery
- After pre-dilation of target lesion, the residual stenosis is ≥ 30% , patients with type B dissection
- Patients must agree to sign the ICF and to undergo the clinical follow-up at 30 days, 6 months, 6 months, 12 months, 24 months, 36months, 48 months and 60 months after operation Criteria related to lesions
- The target lesion length and target vessel diameter should be consistent with the instructions of Drug Eluting PTCA Balloon Catheter（SeQuent® Please）
Who cannot join
- Criteria related to subjects
- Women with pregnancy or lactation
- Patient with cardiac shock
- Patients with Hemorrhagic physique or active gastrointestinal ulcers, with cerebral apoplexy or transient cerebral ischemia within 3 months, who couldn't be tolerated the expected aspirin and/or clopidogrel theory
- Patients with severe valvular heart disease
- Patients with severe congestive heart failure or NYHA class IV heart failure;
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- Patients who have received heart transplant;
- Patients with life expectancy more than 60 months, or those who is difficulties in clinical follow-up.
- Patients who are currently involved in any other clinical trial;
- Patients that the investigators think that those are not suitable Criteria related to lesions
- Chronic total occlusion
- Lesion that cannot be treated with PTCA or other interventional techniques;
- The vessel diameter < 2.25 mm
- Left main disease needed to be treated Exclusion criteria related to concomitant medication
- Patients who are intolerant to aspirin and/or clopidogrel or have a history of neutrophilopenia or thrombocytopenia, or patients with severe hepatic insufficiency and contraindicated for clopidogrel.
- Patients who are known to be intolerant or allergic to heparin, contrast agent, paclitaxel, iopromide, rapamycin, polylactic acid - glycolic acid polymer, stainless steel;
About this study
Official title: To Evaluate the Long Term Safety and Efficacy of Drug Coated Balloon SeQuent® Please in Chinese Coronary Instent Restenosis Patients,a Prospective, Multi-center,Randomization Clinical Trial.
The purpose of this study is to evaluate the efficacy and safety of paclitaxel -eluting PTCA- balloon (SeQuent® Please) in real world Chinese Coronary In Sentrestenosis patients
- Conditions
- Coronary In Sentrestenosis
- Being tested
- paclitaxel-releasing coronary balloon (SeQuent® Please)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel-releasing coronary balloon (SeQuent® Please)Device
SeQuent® Please with a length of 10mm,15mm,17mm,20mm and 26mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure in 12 months after operation
To measure Target Lesion Failure in 12 months by using angiography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start24 Apr 2015
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary In SentrestenosisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 520 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- B. Braun Medical International Trading Company Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624205
- Sponsor's protocol ID
- AAG-O-H-1414
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Long Term Safety and Efficacy of Drug Coated Balloon SeQuent® Please in Chinese Coronary Instent Restenosis Patients,a Prospective, Multi-center,Randomization Clinical Trial.
- ClinicalTrials.gov ID
- NCT03624205
- Acronym / sponsor ID
- AAG-O-H-1414
- Conditions
- Coronary In Sentrestenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (actual)
- Lead sponsor
- B. Braun Medical International Trading Company Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2015 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 10 Aug 2018 (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 purpose of this study is to evaluate the efficacy and safety of paclitaxel -eluting PTCA- balloon (SeQuent® Please) in real world Chinese Coronary In Sentrestenosis patients
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patient with coronary In sentrestenosis
Key inclusion criteria (6 listed)
- Criteria related to subjects
- At the age of 18-80, Both male and female;
- Patients with coronary In sentrestenosis and suitable for the theory of Drug Eluting PTCA Balloon Catheter（SeQuent® Please）, no more than 1 target lesion in each coronary artery
- After pre-dilation of target lesion, the residual stenosis is ≥ 30% , patients with type B dissection
- Patients must agree to sign the ICF and to undergo the clinical follow-up at 30 days, 6 months, 6 months, 12 months, 24 months, 36months, 48 months and 60 months after operation Criteria related to lesions
Key exclusion criteria (16 listed)
- Criteria related to subjects
- Women with pregnancy or lactation
- Patient with cardiac shock
- Patients with Hemorrhagic physique or active gastrointestinal ulcers, with cerebral apoplexy or transient cerebral ischemia within 3 months, who couldn't be tolerated the expected aspirin and/or clopidogrel theory
- Patients with severe valvular heart disease
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 |
|---|---|---|
| paclitaxel-releasing coronary balloon (SeQuent® Please)SeQuent® Please with a length of 10mm,15mm,17mm,20mm and 26mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial | Device | – |
Primary outcome
Target Lesion Failure in 12 months after operation
Time frame: 1 year
To measure Target Lesion Failure in 12 months by using angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary In Sentrestenosis, run by B. Braun Medical International Trading Company Ltd..
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 6 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: status not confirmed, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Target Lesion Failure in 12 months after operation (time frame: 1 year). 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 10 Aug 2018.