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

NCT03373695 | Completed

• 1 other identifier: CL-VP-01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 15

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.

Conditions

Coronary In-stent Restenosis

Outcome Measures

Primary Outcomes (1)

• In-segment Late Lumen Loss

  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.

  From the end of procedure to 9 months after the procedure

Secondary Outcomes (9)

• Device success rate of the interventional therapy

  From the start of index procedure to end of index procedure

• Lesion success rate of the interventional therapy

  From the start of index procedure to end of index procedure

• Clinical success rate of the interventional therapy

  7 days after the procedure

• Rate of restenosis in the target lesions

  9 months after the procedure

• TLR rate

  9 months after the procedure

Study Arms (2)

Dissolve™

EXPERIMENTAL

Device: Dissolve™

SeQuent®Please

ACTIVE COMPARATOR

Device: SeQuent®Please

Interventions

Dissolve™ DEVICE

Dissolve™ are to be used in the trial

Dissolve™

SeQuent®Please DEVICE

SeQuent®Please are to be used in the trial

SeQuent®Please

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:
• 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

You may not qualify if:

• 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

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

The First Affiliated Hospital of Zhengzhou University

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

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 ISR Investigators. A Randomized Comparison of 2 Different Drug-Coated Balloons for In-Stent Restenosis. JACC Cardiovasc Interv. 2023 Apr 10;16(7):759-767. doi: 10.1016/j.jcin.2022.12.018.

  PMID: 37045496 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 5, 2017
• First Posted: December 14, 2017
• Study Start: February 22, 2018
• Primary Completion: January 9, 2020
• Study Completion: April 24, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

CN (15)