A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-stent Restenosis

Not Applicable

Completed

• Conditions: Coronary In-stent Restenosis
• Interventions: Device: Dissolve™; Device: SeQuent®Please

• Registration Number: NCT03373695
• Lead Sponsor: DK Medical Technology (Suzhou) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-10
• Study First Posted: 2017-12-14
• Study Start: 2018-02-22
• Primary Completion: 2020-01-09
• Study Completion: 2024-04-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dissolve™	Dissolve™	-
SeQuent®Please	SeQuent®Please	-

Primary Outcome Measures

Name	Time	Method
In-segment Late Lumen Loss	From the end of procedure to 9 months after the procedure	In-segment late lumen loss is defined as the change in minimal lumen diameter (MLD) within the margins of the device and 5 mm proximal and 5 mm distal to the device from post-procedure to 9 months by angiography.

Secondary Outcome Measures

Name	Time	Method
Device success rate of the interventional therapy	From the start of index procedure to end of index procedure	Successful delivery and use of the assigned balloon at the intended target lesion and successful withdrawal of the delivery system with attainment of final residual stenosis of less than 30% and TIMI 3 blood flow by visual estimation.
Lesion success rate of the interventional therapy	From the start of index procedure to end of index procedure	Attainment of final residual stenosis of target lesion less than 30% and TIMI 3 blood flow by visual estimation.
Rate of restenosis in the target lesions	9 months after the procedure	Restenosis is defined as stenosis \> 30% by angiography
Target lesion failure (TLF) rate	9 months after the procedure
Rate of major adverse cardiovascular events	1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure
TLR rate	9 months after the procedure
Rate of all adverse events and severe adverse events	1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure
Clinical success rate of the interventional therapy	7 days after the procedure	Achievement of final residual stenosis of less than 30% by visual estimation with successful delivery and use of assigned balloon at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel Myocardial Infarction (MI) or repeat Target lesion revascularization (TLR).
Target vessel revascularization (TVR) rate	9 months after the procedure

Trial Locations

Locations (15)

Xiangya Hospital of Central South University; 🇨🇳 Changsha, China

The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

General Hospital of Daqing Oil Field; 🇨🇳 Daqing, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Hangzhou, China

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, China

Peking University People's Hospital, Capital Medical University; 🇨🇳 Beijing, China

Sir Run Run Shaw Hospital, Zhejiang University School of medicine; 🇨🇳 Hangzhou, China

Union Hospital, Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China

The Second Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, China

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, China

Beijing Hospital; 🇨🇳 Beijing, China

Fuwai Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China