Coronary RestenosisNCT02944890
Compare the Efficacy and Safety of RESTORE DEB and SeQuent® Please in Chinese Patient With Coronary In-stent Restenosis
A study testing Drug Eluting Balloon Catheters(RESTORE DEB） and Drug Eluting Balloon Catheters(SeQuent® Please） in people with Coronary Restenosis, run by ZhuHai Cardionovum Medical Device Co., Ltd. at 14 sites in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment and maintaining the vessels unobstructed in the treatment of coronary in-stent restenosis compared with a product of the same category… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Restenosis
- What is being tested?
- Drug Eluting Balloon Catheters(RESTORE DEB） and Drug Eluting Balloon Catheters(SeQuent® Please）
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 14 sitesChina
- Study dates
- May 2016to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Related to the patients:
- Age ≥18 years old
- Patients agree to receive follow-ups in month-1, 6, 9 and 12, and receive angiography in month-9.
- Patients are able to understand the objectives of the study mentally and in language. Patients should indicate sufficient compliance to the study, and acknowledge all risks and benefits by signing the informed consent form.
- Patients with stable angina pectoris, or unstable angina pectoris, or old myocardial infarction, or proved asymptomatic regional myocardial ischemia
- Patients suitable to receive coronary revascularization of any type (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
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- Related to the diseases:
- Restenosis Mehran type I-III after stent implantation (including bare metal stents, stents with inert coating, and stents with active coating) for the first time
- Diameter of the stent with restenosis should be 2.5-4.0mm (included). Length of the stenosis lesion should be no more than 26mm, and diameter stenosis before operation should be ≥70%, or ≥50% with the evidence of ischemia.
- One subject is allowed to have 2 target lesions at most, and 2 Paclitaxel drug balloons for dilation.
- The distance between lesions which require intervention and the target lesions must be >10mm.
Who cannot join
- Related to the patients:
- Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives.
- The patients are participating in any other clinical trials before reaching the primary endpoints.
- The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months.
- The patients had cerebral stroke within 6 months before being included, or have a history of peptic ulcer or gastrointestinal bleeding in the past 6 months, or the patients have a bleeding tendency according to the investigator.
- Patients with a history of leukopenia (white blood cell count <3×109/L for more than 3 days) or neutropenia (ANC<1000/mm3 for more than 3 days) or thrombocytopenia (platelet <100,000/mm3)
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- Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
- Patients with renal insufficiency (eGFR<30mL/min)
- Patients who are known to be allergic to Paclitaxel
- Patients who had myocardial infarction within 1 week before being included
- Patients who had heart transplantation
- Patients with severe congestive heart failure or NYHA grade IV heart failure
- Patients with severe valvular heart disease
- Patients who are unsuitable for the study according to the investigator due to other reasons
- Related to the diseases:
- Patients with evidence of extensive thrombosis in the target vessel before intervention
- Patients with total occlusion indicating TIMI 0 blood flow at the target lesion (Mehran type IV stenosis)
- Patients with multiple lesions (≥3) requiring percutaneous coronary intervention treatment in the same artery
- Patients with lesions requiring intervention treatment in 3 vessels
- The diameter of the branch lesions in the target lesion ≥2.5mm
- Patients already treated with CABG after in-stent restenosis
- LM lesions and Ostial lesion within 5mm to the root aorta
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, 100029
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Cangzhou Central Hospital
Cangzhou, Hebei, 061001
The First Hospital of Jilin University
Changchun, Jilin, 130021
The Second Hospital of Jilin University
Changchun, Jilin, 130041
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163000
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital School of medicine, Zhejiang University
Hangzhou, Zhejiang, 310016
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 30051
Tangdu Hospital
Xi'an, Shaanxi, 710038
About this study
Official title: A Multicenter, Randomized, Controlled Study to Compare the Efficacy and Safety of 2 Types of Drug Eluting Balloon Catheters (RESTORE DEB and SeQuent® Please) in Chinese Patient With Coronary In-stent Restenosis (ISR)
The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment and maintaining the vessels unobstructed in the treatment of coronary in-stent restenosis compared with a product of the same category (SeQuent® Please).
- Conditions
- Coronary Restenosis
- Being tested
- Drug Eluting Balloon Catheters(RESTORE DEB）, Drug Eluting Balloon Catheters(SeQuent® Please）
- Medical subject headings
- Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Eluting Balloon Catheters(RESTORE DEB）Device
Drug Eluting Balloon Catheters(SeQuent® Please）Device
| Study group | Role | What they receive |
|---|---|---|
| RESTORE DEB | Experimental | Conduct Drug Eluting Balloon Catheters(RESTORE DEB） Receives: Device: Drug Eluting Balloon Catheters(RESTORE DEB） |
| SeQuent® Please | Active comparator | Conduct Drug Eluting Balloon Catheters(SeQuent® Please） Receives: Device: Drug Eluting Balloon Catheters(SeQuent® Please） |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment late lumen loss of the target lesion
Measured: 9 months
Secondary outcomes (7)
The success rate of intervention treatment: including device success, lesion success and clinical success
Measured: 1-2 days
Occurrence rate of restenosis in the target lesions
Measured: 9 months after the operation
Target lesion revascularization (TLR) rate
Measured: 1, 6, 9, and 12 months after the operation
Target vessel revascularization (TVR) rate
Measured: 1, 6, 9, and 12 months after the operation
Target lesion failure (TLF) rate
Measured: 1, 6, 9, and 12 months after the operation
Occurrence rate of major adverse cardiovascular events
Measured: 1, 6, 9, and 12 months after the operation
All adverse events and severe adverse events
Measured: 1, 6, 9, and 12 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2018
- Study completionMay 2019
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 Coronary RestenosisStudies 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
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Responsible party
- Sponsor
- Investigators
- Yundai Chen, PhD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944890
- Sponsor's protocol ID
- RG01W-1101
- Status last verified
- Jul 2017
- First submitted
- 24 Oct 2016
- Last updated
- 29 Jul 2019
- Results posted
- No
Publications
Chen Y, Gao L, Qin Q, Chen S, Zhang J, Chen H, Wang L, Jin Z, Zheng Y, Zhang Z, Li H, Li X, Fu G, Chen L, Sun Z, Wang Y, Jin Q, Cao F, Guo J, Zhao Y, Guan C, Li W, Xu B; RESTORE ISR China Investigators. Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis: The RESTORE ISR China Randomized Trial. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2368-2377. doi: 10.1016/j.jcin.2018.09.010.
PubMed 30522665
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Study to Compare the Efficacy and Safety of 2 Types of Drug Eluting Balloon Catheters (RESTORE DEB and SeQuent® Please) in Chinese Patient With Coronary In-stent Restenosis (ISR)
- ClinicalTrials.gov ID
- NCT02944890
- Acronym / sponsor ID
- RG01W-1101
- Conditions
- Coronary Restenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Study start
- May 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 26 Oct 2016 (estimated)
- 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 safety and efficacy of Paclitaxel drug eluting balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment and maintaining the vessels unobstructed in the treatment of coronary in-stent restenosis compared with a product of the same category (SeQuent® Please).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RESTORE DEB | Experimental | Device: Drug Eluting Balloon Catheters(RESTORE DEB）Conduct Drug Eluting Balloon Catheters(RESTORE DEB） |
| SeQuent® Please | Active comparator | Device: Drug Eluting Balloon Catheters(SeQuent® Please）Conduct Drug Eluting Balloon Catheters(SeQuent® Please） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years old
- Patients agree to receive follow-ups in month-1, 6, 9 and 12, and receive angiography in month-9.
- Patients are able to understand the objectives of the study mentally and in language. Patients should indicate sufficient compliance to the study, and acknowledge all risks and benefits by signing the informed consent form.
- Patients with stable angina pectoris, or unstable angina pectoris, or old myocardial infarction, or proved asymptomatic regional myocardial ischemia
- Patients suitable to receive coronary revascularization of any type (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
Key exclusion criteria (22 listed)
- Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives.
- The patients are participating in any other clinical trials before reaching the primary endpoints.
- The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months.
- The patients had cerebral stroke within 6 months before being included, or have a history of peptic ulcer or gastrointestinal bleeding in the past 6 months, or the patients have a bleeding tendency according to the investigator.
- Patients with a history of leukopenia (white blood cell count <3×109/L for more than 3 days) or neutropenia (ANC<1000/mm3 for more than 3 days) or thrombocytopenia (platelet <100,000/mm3)
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 |
|---|---|---|
| Drug Eluting Balloon Catheters(RESTORE DEB） | Device | RESTORE DEB |
| Drug Eluting Balloon Catheters(SeQuent® Please） | Device | SeQuent® Please |
Primary outcome
In-segment late lumen loss of the target lesion
Time frame: 9 months
7 secondary outcomes
The success rate of intervention treatment: including device success, lesion success and clinical success
Time frame: 1-2 days
Occurrence rate of restenosis in the target lesions
Time frame: 9 months after the operation
Target lesion revascularization (TLR) rate
Time frame: 1, 6, 9, and 12 months after the operation
Target vessel revascularization (TVR) rate
Time frame: 1, 6, 9, and 12 months after the operation
Target lesion failure (TLF) rate
Time frame: 1, 6, 9, and 12 months after the operation
Occurrence rate of major adverse cardiovascular events
Time frame: 1, 6, 9, and 12 months after the operation
All adverse events and severe adverse events
Time frame: 1, 6, 9, and 12 months after the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Derived from this study: PubMed 30522665Chen Y, Gao L, Qin Q, Chen S, Zhang J, Chen H, Wang L, Jin Z, Zheng Y, Zhang Z, Li H, Li X, Fu G, Chen L, Sun Z, Wang Y, Jin Q, Cao F, Guo J, Zhao Y, Guan C, Li W, Xu B; RESTORE ISR China Investigators. Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis: The RESTORE ISR China Randomized Trial. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2368-2377. doi: 10.1016/j.jcin.2018.09.010.
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Virtue® SAB in the Treatment of Coronary ISR Trial
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Prevail Global Study
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SELUTION SLR™ 014 In-stent Restenosis
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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.
Yundai Chen, PhD principal investigator
Chinese PLA General Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug Eluting Balloon Catheters(RESTORE DEB） and Drug Eluting Balloon Catheters(SeQuent® Please） in people with Coronary Restenosis, run by ZhuHai Cardionovum Medical Device Co., Ltd. at 14 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 11 inclusion and 22 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: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
In-segment late lumen loss of the target lesion (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 NCT02944890, 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 29 Jul 2019.