Compare the Efficacy and Safety of RESTORE DEB and SeQuent® Please in Chinese Patient With Coronary In-stent Restenosis
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)
1 other identifier
interventional
242
1 country
14
Brief 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 (SeQuent® Please).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 24, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedJuly 29, 2019
July 1, 2017
2.1 years
October 24, 2016
July 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
In-segment late lumen loss of the target lesion
9 months
Secondary Outcomes (7)
The success rate of intervention treatment: including device success, lesion success and clinical success
1-2 days
Occurrence rate of restenosis in the target lesions
9 months after the operation
Target lesion revascularization (TLR) rate
1, 6, 9, and 12 months after the operation
Target vessel revascularization (TVR) rate
1, 6, 9, and 12 months after the operation
Target lesion failure (TLF) rate
1, 6, 9, and 12 months after the operation
- +2 more secondary outcomes
Study Arms (2)
RESTORE DEB
EXPERIMENTALConduct Drug Eluting Balloon Catheters(RESTORE DEB）
SeQuent® Please
ACTIVE COMPARATORConduct Drug Eluting Balloon Catheters(SeQuent® Please）
Interventions
Eligibility Criteria
You may qualify if:
- 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)
- 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.
You may not qualify if:
- 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)
- 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:
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020, China
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, 100029, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061001, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163000, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
Tangdu Hospital
Xi'an, Shaanxi, 710038, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 30051, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital School of medicine, Zhejiang University
Hangzhou, Zhejiang, 310016, China
Related Publications (1)
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.
PMID: 30522665DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yundai Chen, PhD
Chinese PLA General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2016
First Posted
October 26, 2016
Study Start
May 1, 2016
Primary Completion
June 1, 2018
Study Completion
May 1, 2019
Last Updated
July 29, 2019
Record last verified: 2017-07