Clinical trial NCT03376646: A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary Small Vessel Disease
Official title: A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to Resolute™ Integrity in Treatment of Coronary Small Vessel Disease in Chinese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Small Vessel Disease
Lead sponsor: DK Medical Technology (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Core Medical (Beijing) Co., Ltd.
First posted: 2017-12-18
Enrollment: 277
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 in the treatment of Coronary Small Vessel Disease by drug coated balloon (DCB) Dissolve™ versus drug eluting stent (DES) Resolute™ Integrity.


Eligibility criteria: Inclusion Criteria:

Related to the patients:

Cohort A:

1. 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
2. Patients with stable angina, unstable angina, old myocardial infarction (including ST elevation MI or Non-ST elevation MI) or proven asymptomatic ischemia
3. Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)

   Cohort B: All candidates for Cohort B of this study must meet number 1, 2 of the above criteria and
4. Patients who can receive balloon angioplasty

   Related to lesion:

   Cohort A
5. The reference blood vessel diameter is 2.25 mm-2.75 mm, length ≤ 26mm
6. Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia
7. One subject is allowed to have 1 target lesion at most (Two lesions can be treat as one target lesion, if they are in the same vessel, with the distance less than 10mm, with total length ≤ 26mm, and can be intervened by one DCB or DES)

   Cohort B: All candidates for Cohort B of this study must meet number 6,7 of the above criteria and
8. The reference blood vessel diameter is 2.00mm-2.25mm

Exclusion Criteria:

Related to patients

1. Patients who had Myocardial Infarction within 1 week before being included
2. Patients with severe congestive heart failure or NYHA grade IV heart failure
3. Left ventricular ejection fraction (LVEF) \< 35%
4. Patients who had heart transplantation
5. Patients with severe valvular heart disease
6. 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
7. Patients with leukopenia (white blood cell count \< 3×10\^9/L) for more than three days; Patients with low neutrophil counts (ANC \< 1000/mm\^3) for more than three days; Patients with thrombocytopenia (platelet count \< 100,000/mm\^3)
8. Patients with renal insufficiency (eGFR \< 30mL/min)
9. Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
10. Patients who are allergic to Paclitaxel or Zotarolimus
11. The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months
12. Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives
13. The patients are participating in any other clinical trials before reaching the primary endpoints
14. Patients who are unsuitable for the study according to the investigator due to other reasons

    Related to the Lesion:
15. Patients with total occlusion at the target lesion
16. Patients who have severe calcification of the target lesion, and balloon pre-dilatation could not be performed successfully
17. The target lesions are bifurcation lesion with the diameter of the branch vessel \> 2.00mm
18. The target lesions are in-stent restenosis
19. Angiography indicates thrombosis in the target vessel
20. Complicated with lesions in left main (LM) coronary requiring intervention treatment
21. More than 2 non-target lesions need treatment, or the non-target lesion could not be intervened successfully before the target lesion

Primary outcomes:
measure: In-segment percent diameter stenosis of the target lesion at 9 months after procedure
timeFrame: 9 months after the procedure
Secondary outcomes:
measure: Device success rate of the interventional therapy
timeFrame: From the start of index procedure to the end of index procedure, Day 0
measure: Lesion success rate of the interventional therapy
timeFrame: From the start of index procedure to the end of index procedure, Day 0
measure: Clinical success rate of the interventional therapy
timeFrame: 7 days after the procedure
measure: In-device percent diameter stenosis of the target lesion
timeFrame: 9 months after the procedure
measure: In-device minimal lumen diameter (MLD)
timeFrame: 9 months after the procedure
measure: In-segment MLD
timeFrame: 9 months after the procedure
measure: In-device late lumen loss (LLL)
timeFrame: 9 months after the procedure
measure: In-segment LLL
timeFrame: 9 months after the procedure
measure: Binary restenosis rate in lesion section
timeFrame: 9 months after the procedure
measure: Target vessel revascularization (TVR) rate
timeFrame: 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure
measure: Target lesion failure (TLF) rate
timeFrame: 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure
measure: Target lesion revascularization (TLR) rate
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
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
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: 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
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shubin Qiao
role: PRINCIPAL_INVESTIGATOR
References: