Status:
COMPLETED
A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-stent Restenosis
Lead Sponsor:
DK Medical Technology (Suzhou) Co., Ltd.
Collaborating Sponsors:
Core Medical (Beijing) Co., Ltd.
Conditions:
Coronary In-stent Restenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Related to the patients:
- Age ≥18 years old
- 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
- Patients with stable angina, unstable angina, old myocardial infarction or proven asymptomatic ischemia
- Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
- Related to lesion:
- 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
- Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia
- The distance between other lesion requires interventional therapy and the target lesion must be \> 10mm
- One subject is allowed to have 2 target lesions at most, and 1 paclitaxel drug balloon for each lesion for dilation
- Residual stenosis must be ≤ 30% after pre-dilatation, and dissection must be ≤ NHLBI type B
Exclusion
- Related to patients
- Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives
- Patients with cardiogenic shock
- 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
- Patients who have Myocardial Infarction with thrombus or coronary slow flow symptoms and require immediate intervention
- Patients who had ST-Elevation Myocardial Infarction within 1 week before being included
- Patients with severe congestive heart failure or NYHA grade IV heart failure
- Patients with moderate or severe valvular heart disease
- Patients who had heart transplantation
- Patients with renal insufficiency (eGFR \< 30mL/min)
- 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 are participating in any other clinical trials before reaching the primary endpoints
- Patients who are unsuitable for the study according to the investigator due to other reasons
- Related to the Lesion:
- Patients with total occlusion at the target lesion
- Lesion which cannot be treated by percutaneous transluminal coronary angioplasty (PTCA) or percutaneous intervention (PCI)
- Reference vessel diameter \< 2.0mm
- Patients with multiple lesions (≥ 3) requiring percutaneous coronary intervention treatment in the same artery
- 3-vessel disease that all need to be intervened
- The diameter of the branch lesions in the target lesion ≥ 2.5mm
- LM lesions and Ostial lesion within 5mm to the root aorta
- Non-target lesion was not intervened successfully before target lesions being intervened
- Related to concomitant therapy:
- 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
- Patients known allergic to paclitaxel
- Patients known allergic to contrast materials
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2024
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03373695
Start Date
February 22 2018
End Date
April 24 2024
Last Update
February 20 2025
Active Locations (15)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
2
Beijing Friendship Hospital, Capital Medical University
Beijing, China
3
Beijing Hospital
Beijing, China
4
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China