Small Vessel DiseaseNCT03625830
The Efficacy and Safety of SeQuent® Please in the Treatment of Small Vessel Disease (SVD) Patient
A study testing Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) and rapid exchange PTCA -Balloon Catheter (SeQuent® Neo) in people with Small Vessel Disease, run by B. Braun Medical International Trading Company Ltd. at 1 site in China.
Trial summary
The purpose is to evaluate the safety and effectiveness of paclitaxel-releasing coronary balloon (Catheter SeQuent® Please) versus rapid exchange PTCA balloon catheter (SeQuent® Neo) in the treatment of stenoses of coronary small vessels. 270 subjects will be enrolled for the trials. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Small Vessel Disease
- What is being tested?
- Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) and rapid exchange PTCA -Balloon Catheter (SeQuent® Neo)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2017to 30 Dec 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Criteria related to subjects
- Patients with stable angina pectoris, or unstable angina pectoris, or old myocardial infarction, or documented silent ischemia;
- At the age of 18-80;
- Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the study. Hence, patients will be advised to use an adequate birth control method up to (including) the end of follow-up;
- Patients must agree to undergo the 9-month angiographic follow-up and the clinical follow-up at 30 days, 6 months, 9 months and 12 months after operation;
- Patients who are psychologically and linguistically able to understand the purpose of the study, and show sufficient compliance with the study protocol;
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- Patients who have expressed acknowledgment of the risks and benefits described in the informed consent document by providing informed consent;
- Criteria related to lesions
- The target lesion is primary, in situ coronary artery lesion located in 1 or 2 different coronary arteries, with no more than 1 target lesion in each coronary artery;
- The reference vessel diameter is within the range of 2.0 mm - 2.75 mm; (visually measured)
- Interventional treatment should be conducted on lesion(s) of non-target vessel(s) in advance (which must be concurrent treatment), and management of random and target lesions should be performed after successful treatment of non-target lesion(s);
- The pre-operative diameter stenosis must be either ≥ 70% or ≥ 50% with ischemia; (visually measured)
- Each target lesion should be treated with only one SeQuent® Please or SeQuent® Neo.
Who cannot join
- Criteria related to subjects
- Patients with recent myocardial infarction (within one week), or patients with myocardial infarction over one week but whose troponin level has not recovered to normal;
- Patients with severe congestive heart failure or NYHA class IV heart failure;
- Patients with severe valvular heart disease;
- Women who are pregnant or lactating;
- Patients with remaining life expectancy of no more than 1 year or with factors causing difficulty in clinical follow-up;
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- Patients who had cerebral stroke within 6 months before operation;
- Patients who are currently involved in any other clinical trial;
- Patients with presence or history of severe hepatic failure and therefore are not eligible for angiography;
- Patients with presence or history of severe renal failure (GFR < 30 ml/min) and therefore are not eligible for angiography;
- Patients who have received heart transplant;
- Patients with cardiogenic shock;
- Patients with left ventricular ejection fraction less than 30%;
- Patients suffering from coronary artery spasm without significant stenosis;
- Patients considered as ineligible by the investigator for other reasons;
- Criteria related to lesions
- Evidence of extensive thrombosis in target vessel before intervention;
- Percutaneous coronary intervention of venous graft;
- Chronic total occlusion (TIMI 0 flow before operation);
- Left main disease and/or triple vessel disease needed to be treated, bifurcation lesion with branch vessel diameter ≥ 2.5 mm, and bypass graft lesion;
- There is non-target lesion(s) in the proximal large vessel and target lesion(s) in the distal small vessel of the same vessel (eligible if there is non-target lesion(s) in proximal large vessel and a target lesion in the bifurcated small vessel);
- The target vessel is distorted or has calcified lesion(s);
- Lesion within 5 mm away from the coronary artery ostium;
- Lesion that cannot be treated with PTCA or other interventional techniques;
- After pre-dilation of target lesion, the residual stenosis is ≥ 30% or TIMI flow is < 3, and/or type C or above dissection appears;
- Patients prone to bleeding and contraindicated for anticoagulant or antiplatelet drugs;
- 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;
- Patients with a history of leukopenia (leukocyte count < 3 × 109/L for more than 3 days), neutrophilopenia (ANC < 1,000 neutrophils/mm3 for more than 3 days), or thrombocytopenia (< 100,000 platelets/mm3);
- Patients with a history of peptic ulcer or gastrointestinal bleeding in the past 6 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality
Jun Bo Ge, Academician, +86 21 64041990 ext. 2745, ge.junbo@zs-hospital.sh.cn
About this study
Official title: A Randomized, Multicenter Study on the Efficacy and Safety of Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) Compared to POBA in the Treatment of Small Vessel Disease (SVD) Patient
The purpose is to evaluate the safety and effectiveness of paclitaxel-releasing coronary balloon (Catheter SeQuent® Please) versus rapid exchange PTCA balloon catheter (SeQuent® Neo) in the treatment of stenoses of coronary small vessels. 270 subjects will be enrolled for the trials.
- Conditions
- Small Vessel Disease
- Being tested
- Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please), rapid exchange PTCA -Balloon Catheter (SeQuent® Neo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please)Device
SeQuent® Please in length of 10 mm, 15 mm, 17 mm, 20 mm, 26 mm, 30 mm and in diameter of 2.0 mm, 2.5mm, 2.75mm will be used in the trial.
rapid exchange PTCA -Balloon Catheter (SeQuent® Neo)Device
SeQuent® Please in length of 10 mm, 15 mm, 17 mm, 20 mm, 26 mm, 30 mm and in diameter of 2.0 mm, 2.5mm, 2.75mm will be used in the trial.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) | Experimental | Not described Receives: Device: Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) |
| Rapid exchange PTCA Balloon Catheter (SeQuent® Neo) | Active comparator | Not described Receives: Device: rapid exchange PTCA -Balloon Catheter (SeQuent® Neo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late lumen loss in segment section at M9
To measure the diameter loss in the in-segment late lumen loss (LLL) at 9 months after operation by using angiography
Measured: 9 months
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 start18 Dec 2017
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Vessel 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (estimated)
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
- NCT03625830
- Sponsor's protocol ID
- AAG-G-H-1518
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu K, Fu X, Yang W, Wu Y, Li C, Ding D, Wang Z, Chu M, Qian J, He B, Tu S, Shen L, Ge J. A novel angiographic index for predicting the efficacy of drug-coated balloons in small vessels. EuroIntervention. 2025 Oct 20;21(20):e1209-e1221. doi: 10.4244/EIJ-D-25-00075.
PubMed 41117656
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter Study on the Efficacy and Safety of Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) Compared to POBA in the Treatment of Small Vessel Disease (SVD) Patient
- ClinicalTrials.gov ID
- NCT03625830
- Acronym / sponsor ID
- AAG-G-H-1518
- Conditions
- Small Vessel Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- B. Braun Medical International Trading Company Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Dec 2019 (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 is to evaluate the safety and effectiveness of paclitaxel-releasing coronary balloon (Catheter SeQuent® Please) versus rapid exchange PTCA balloon catheter (SeQuent® Neo) in the treatment of stenoses of coronary small vessels. 270 subjects will be enrolled for the trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) | Experimental | Device: Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) |
| Rapid exchange PTCA Balloon Catheter (SeQuent® Neo) | Active comparator | Device: rapid exchange PTCA -Balloon Catheter (SeQuent® Neo) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Criteria related to subjects
- Patients with stable angina pectoris, or unstable angina pectoris, or old myocardial infarction, or documented silent ischemia;
- At the age of 18-80;
- Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the study. Hence, patients will be advised to use an adequate birth control method up to (including) the end of follow-up;
- Patients must agree to undergo the 9-month angiographic follow-up and the clinical follow-up at 30 days, 6 months, 9 months and 12 months after operation;
Key exclusion criteria (30 listed)
- Criteria related to subjects
- Patients with recent myocardial infarction (within one week), or patients with myocardial infarction over one week but whose troponin level has not recovered to normal;
- Patients with severe congestive heart failure or NYHA class IV heart failure;
- Patients with severe valvular heart disease;
- Women who are pregnant or lactating;
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-eluting PTCA-Balloon Catheter(SeQuent® Please)SeQuent® Please in length of 10 mm, 15 mm, 17 mm, 20 mm, 26 mm, 30 mm and in diameter of 2.0 mm, 2.5mm, 2.75mm will be used in the trial. | Device | Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) |
| rapid exchange PTCA -Balloon Catheter (SeQuent® Neo)SeQuent® Please in length of 10 mm, 15 mm, 17 mm, 20 mm, 26 mm, 30 mm and in diameter of 2.0 mm, 2.5mm, 2.75mm will be used in the trial. | Device | Rapid exchange PTCA Balloon Catheter (SeQuent® Neo) |
Primary outcome
Late lumen loss in segment section at M9
Time frame: 9 months
To measure the diameter loss in the in-segment late lumen loss (LLL) at 9 months after operation 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 16 Jan 2019.
- Derived from this study: PubMed 41117656Xu K, Fu X, Yang W, Wu Y, Li C, Ding D, Wang Z, Chu M, Qian J, He B, Tu S, Shen L, Ge J. A novel angiographic index for predicting the efficacy of drug-coated balloons in small vessels. EuroIntervention. 2025 Oct 20;21(20):e1209-e1221. doi: 10.4244/EIJ-D-25-00075.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) and rapid exchange PTCA -Balloon Catheter (SeQuent® Neo) in people with Small Vessel Disease, run by B. Braun Medical International Trading Company Ltd. at 1 site 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 13 inclusion and 30 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 16 Jan 2019. 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 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?
Contact Jun Bo Ge (+86 21 64041990 ext. 2745, lcsyjg@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late lumen loss in segment section at M9 (time frame: 9 months). 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 NCT03625830, which also lists 1 linked publication.
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 16 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.