A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary Small Vessel Disease

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Small Vessel Disease
• Intervention / Treatment: Device: Cohort A: Dissolve™; Device: Cohort A: Resolute™ Integrity; Device: Cohort B: Dissolve™-2.00mm

• Study Type: Interventional
• Enrollment (Actual): 277
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Friendship Hospital, Capital Medical University
  • Beijing, China
    • Beijing Hospital
  • Beijing, China
    • Peking Union Medical College Hospital
  • Beijing, China
    • Beijing Anzhen Hospital, Capital Medical University
  • Beijing, China
    • Fuwai Hospital, Chinese Academy of Medical Sciences
  • Beijing, China
    • Peking University People's Hospital, Capital Medical University
  • Changsha, China
    • Xiangya Hospital of Central South University
  • Chengdu, China
    • West China Hospital, Sichuan University
  • Dalian, China
    • The Second Affiliated Hospital of Dalian Medical University
  • Dalian, China
    • The First Affiliated Hospital of Dalian Medical University
  • Daqing, China
    • General Hospital of Daqing Oil Field
  • Hangzhou, China
    • Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine
  • Wuhan, China
    • Union Hospital, Tongji Medical College Huazhong University of Science and Technology
  • Yinchuan, China
    • General Hospital of Ningxia Medical University
  • Zhengzhou, China
    • The First Affiliated hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: Dissolve™	Device: Cohort A: Dissolve™; Dissolve™ are to be used in the trial; Other Names: Paclitaxel coated balloon
Active Comparator: Cohort A: Resolute™ Integrity	Device: Cohort A: Resolute™ Integrity; Resolute™ Integrity are to be used in the trial; Other Names: Zotarolimus eluting stent
Experimental: Cohort B: Dissolve™-2.00mm; Cohort B is single arm.	Device: Cohort B: Dissolve™-2.00mm; Dissolve™ are to be used in the trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-segment percent diameter stenosis of the target lesion at 9 months after procedure	9 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Device success rate of the interventional therapy	Successful delivery and use of the assigned balloon/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final residual stenosis of less than 50% and TIMI 3 blood flow (DCB arm) or less than 30% and TIMI 3 blood flow (DES arm) by visual estimation	From the start of index procedure to the end of index procedure, Day 0
Lesion success rate of the interventional therapy	Attainment of final residual stenosis of less than 50% and TIMI 3 blood flow (DCB arm) or less than 30% and TIMI 3 blood flow (DES arm) by visual estimation.	From the start of index procedure to the end of index procedure, Day 0
Clinical success rate of the interventional therapy	Without the occurrence of cardiac death, target vessel Myocardial Infarction (MI) or repeat target lesion revascularization (TLR).	7 days after the procedure
In-device percent diameter stenosis of the target lesion	Restenosis is defined as stenosis > 50% by angiography	9 months after the procedure
In-device minimal lumen diameter (MLD)		9 months after the procedure
In-segment MLD		9 months after the procedure
In-device late lumen loss (LLL)		9 months after the procedure
In-segment LLL		9 months after the procedure
Binary restenosis rate in lesion section		9 months after the procedure
Target vessel revascularization (TVR) rate		1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure
Target lesion failure (TLF) rate		1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure
Target lesion revascularization (TLR) rate		1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure
Rate of major adverse cardiovascular events	Including death, myocardial infarction (MI), stroke and renal failure	1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure

Collaborators and Investigators

• Sponsor: DK Medical Technology (Suzhou) Co., Ltd.
• Collaborators: Core Medical (Beijing) Co., Ltd.
• Investigators: Principal Investigator: Shubin Qiao, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Actual): January 10, 2020
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 17, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: CL-VP-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No