Clinical trial NCT03373695: A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-stent Restenosis
Official title: A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to SeQuent® Please in Treatment of Coronary In-stent Restenosis in Chinese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary In-stent Restenosis
Lead sponsor: DK Medical Technology (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Core Medical (Beijing) Co., Ltd.
First posted: 2017-12-14
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of treatment of coronary in-stent restenosis by Paclitaxel-eluting balloon catheter Dissolve™ versus SeQuent®Please, and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤ 26mm.


Eligibility criteria: Inclusion Criteria:

Related to the patients:

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:

Related to patients

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

Primary outcomes:
measure: In-segment Late Lumen Loss
timeFrame: From the end of procedure to 9 months after the procedure
Secondary outcomes:
measure: Device success rate of the interventional therapy
timeFrame: From the start of index procedure to end of index procedure
measure: Lesion success rate of the interventional therapy
timeFrame: From the start of index procedure to end of index procedure
measure: Clinical success rate of the interventional therapy
timeFrame: 7 days after the procedure
measure: Rate of restenosis in the target lesions
timeFrame: 9 months after the procedure
measure: TLR rate
timeFrame: 9 months after the procedure
measure: Target vessel revascularization (TVR) rate
timeFrame: 9 months after the procedure
measure: Target lesion failure (TLF) rate
timeFrame: 9 months after the procedure
measure: Rate of major adverse cardiovascular events
timeFrame: 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure
measure: Rate of all adverse events and severe adverse events
timeFrame: 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University People's Hospital, Capital Medical University
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
city: Dalian
country: China
facility: The Second Affiliated Hospital of Dalian Medical University
city: Daqing
country: China
facility: General Hospital of Daqing Oil Field
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of medicine
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College Huazhong University of Science and Technology
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shubin Qiao
role: PRINCIPAL_INVESTIGATOR
References: