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

NCT03376646 | Completed

• 1 other identifier: CL-VP-02
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 15

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.

Conditions

Coronary Small Vessel Disease

Outcome Measures

Primary Outcomes (1)

• In-segment percent diameter stenosis of the target lesion at 9 months after procedure

  9 months after the procedure

Secondary Outcomes (14)

• Device success rate of the interventional therapy

  From the start of index procedure to the end of index procedure, Day 0

• Lesion success rate of the interventional therapy

  From the start of index procedure to the end of index procedure, Day 0

• Clinical success rate of the interventional therapy

  7 days after the procedure

• In-device percent diameter stenosis of the target lesion

  9 months after the procedure

• In-device minimal lumen diameter (MLD)

  9 months after the procedure

Study Arms (3)

Cohort A: Dissolve™

EXPERIMENTAL

Device: Cohort A: Dissolve™

Cohort A: Resolute™ Integrity

ACTIVE COMPARATOR

Device: Cohort A: Resolute™ Integrity

Cohort B: Dissolve™-2.00mm

EXPERIMENTAL

Cohort B is single arm.

Device: Cohort B: Dissolve™-2.00mm

Interventions

Cohort A: Dissolve™ DEVICE

Dissolve™ are to be used in the trial

Also known as: Paclitaxel coated balloon

Cohort A: Dissolve™

Cohort A: Resolute™ Integrity DEVICE

Resolute™ Integrity are to be used in the trial

Also known as: Zotarolimus eluting stent

Cohort A: Resolute™ Integrity

Cohort B: Dissolve™-2.00mm DEVICE

Dissolve™ are to be used in the trial

Cohort B: Dissolve™-2.00mm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Related to the patients:
• Cohort A:
• 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 (including ST elevation MI or Non-ST elevation MI) or proven asymptomatic ischemia
• 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
• Patients who can receive balloon angioplasty
• Related to lesion:
• Cohort A
• The reference blood vessel diameter is 2.25 mm-2.75 mm, length ≤ 26mm
• Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia
• 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
• The reference blood vessel diameter is 2.00mm-2.25mm

You may not qualify if:

• Related to patients
• Patients who had Myocardial Infarction within 1 week before being included
• Patients with severe congestive heart failure or NYHA grade IV heart failure
• Left ventricular ejection fraction (LVEF) \< 35%
• Patients who had heart transplantation
• Patients with severe valvular heart disease
• 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 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)
• Patients with renal insufficiency (eGFR \< 30mL/min)
• Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
• Patients who are allergic to Paclitaxel or Zotarolimus
• The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months
• Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives
• 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

Sponsors & Collaborators

• DK Medical Technology (Suzhou) Co., Ltd.: lead
• Core Medical (Beijing) Co., Ltd.: collaborator

Study Sites (15)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

Beijing Hospital

Beijing, China

Location

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Peking University People's Hospital, Capital Medical University

Beijing, China

Location

Xiangya Hospital of Central South University

Changsha, China

Location

West China Hospital, Sichuan University

Chengdu, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, China

Location

The Second Affiliated Hospital of Dalian Medical University

Dalian, China

Location

General Hospital of Daqing Oil Field

Daqing, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of medicine

Hangzhou, China

Location

Union Hospital, Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Location

General Hospital of Ningxia Medical University

Yinchuan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Related Publications (1)

• Liu S, Zhou Y, Shen Z, Chen H, Qiu C, Fu G, Li H, Yu Z, Zeng Q, Li Z, Li W, Qiao S; Dissolve SVD investigators. Comparison of Drug-Coated Balloon and Drug-Eluting Stent for the Treatment of Small Vessel Disease (from the Dissolve SVD Randomized Trial). Am J Cardiol. 2024 Jan 15;211:29-39. doi: 10.1016/j.amjcard.2023.05.057. Epub 2023 Nov 22.

  PMID: 37995506 DERIVED

Study Officials

• Shubin Qiao

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 18, 2017
• Study Start: June 20, 2018
• Primary Completion: January 10, 2020
• Study Completion: April 15, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

CN (15)