A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-stent Restenosis
NCT ID: NCT03373695
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
260 participants
INTERVENTIONAL
2018-02-22
2024-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dissolve™
Dissolve™
Dissolve™ are to be used in the trial
SeQuent®Please
SeQuent®Please
SeQuent®Please are to be used in the trial
Interventions
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Dissolve™
Dissolve™ are to be used in the trial
SeQuent®Please
SeQuent®Please are to be used in the trial
Eligibility Criteria
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Inclusion Criteria
1. Age ≥18 years old
2. Patients who agree to accept the angiography follow-up visit at 9-month and follow up visits at 1-month, 6-month, 9-month, 1-year, 2-year, 3-year, 4-year and 5-year
3. Patients with stable angina, unstable angina, old myocardial infarction or proven asymptomatic ischemia
4. Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
Related to lesion:
5. Restenosis after the first stent implant (including bare metal stents, stents with inert coating, and stents with active coating): Type Mehran I, Type II and Type III; the reference blood vessel diameter is 2.5 mm-4.0 mm, length ≤ 26mm
6. Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia
7. The distance between other lesion requires interventional therapy and the target lesion must be \> 10mm
8. One subject is allowed to have 2 target lesions at most, and 1 paclitaxel drug balloon for each lesion for dilation
9. Residual stenosis must be ≤ 30% after pre-dilatation, and dissection must be ≤ NHLBI type B
Exclusion Criteria
1. Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives
2. Patients with cardiogenic shock
3. The patients had cerebral stroke within 6 months before being included, or have a history of peptic ulcer or gastrointestinal bleeding, or the patients have a bleeding tendency according to the investigator. Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate aspirin or clopidogrel. Patients who are not able to tolerate and comply with dual antiplatelet therapy for at least 3 months after operation
4. Patients who have Myocardial Infarction with thrombus or coronary slow flow symptoms and require immediate intervention
5. Patients who had ST-Elevation Myocardial Infarction within 1 week before being included
6. Patients with severe congestive heart failure or NYHA grade IV heart failure
7. Patients with moderate or severe valvular heart disease
8. Patients who had heart transplantation
9. Patients with renal insufficiency (eGFR \< 30mL/min)
10. The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months.
11. The patients are participating in any other clinical trials before reaching the primary endpoints
12. Patients who are unsuitable for the study according to the investigator due to other reasons
Related to the Lesion:
13. Patients with total occlusion at the target lesion
14. Lesion which cannot be treated by percutaneous transluminal coronary angioplasty (PTCA) or percutaneous intervention (PCI)
15. Reference vessel diameter \< 2.0mm
16. Patients with multiple lesions (≥ 3) requiring percutaneous coronary intervention treatment in the same artery
17. 3-vessel disease that all need to be intervened
18. The diameter of the branch lesions in the target lesion ≥ 2.5mm
19. LM lesions and Ostial lesion within 5mm to the root aorta
20. Non-target lesion was not intervened successfully before target lesions being intervened
Related to concomitant therapy:
21. Patients cannot tolerate aspirin and/or clopidogrel and or tricagrelor, patients with the history of neutrocytopenia or thrombocytopenia, or patients with severe hypohepatia and prohibited to take clopidogrel
22. Patients known allergic to paclitaxel
23. Patients known allergic to contrast materials
18 Years
ALL
No
Sponsors
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Core Medical (Beijing) Co., Ltd.
OTHER
DK Medical Technology (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Shubin Qiao
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Beijing Anzhen Hospital, Capital Medical University
Beijing, , China
Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Beijing Hospital
Beijing, , China
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Peking University People's Hospital, Capital Medical University
Beijing, , China
Xiangya Hospital of Central South University
Changsha, , China
West China Hospital, Sichuan University
Chengdu, , China
The First Affiliated Hospital of Dalian Medical University
Dalian, , China
The Second Affiliated Hospital of Dalian Medical University
Dalian, , China
General Hospital of Daqing Oil Field
Daqing, , China
Sir Run Run Shaw Hospital, Zhejiang University School of medicine
Hangzhou, , China
The First Affiliated Hospital of Zhengzhou University
Hangzhou, , China
Union Hospital, Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
General Hospital of Ningxia Medical University
Yinchuan, , China
Countries
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References
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Liu S, Zhou Y, Shen Z, Chen H, Qiu C, Fu G, Li H, Yu Z, Zeng Q, Li Z, Li W, Qiao S; Dissolve ISR Investigators. A Randomized Comparison of 2 Different Drug-Coated Balloons for In-Stent Restenosis. JACC Cardiovasc Interv. 2023 Apr 10;16(7):759-767. doi: 10.1016/j.jcin.2022.12.018.
Other Identifiers
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CL-VP-01
Identifier Type: -
Identifier Source: org_study_id
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