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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03376646
Recruitment Status : Active, not recruiting
First Posted : December 18, 2017
Last Update Posted : December 9, 2019
Sponsor:
Collaborator:
Core Medical (Beijing) Co., Ltd.
Information provided by (Responsible Party):
DK Medical Technology (Suzhou) Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Coronary Small Vessel Disease Device: Cohort A: Dissolve™ Device: Cohort A: Resolute™ Integrity Device: Cohort B: Dissolve™-2.00mm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 20, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: Cohort A: Dissolve™ Device: Cohort A: Dissolve™
Dissolve™ are to be used in the trial
Other Name: Paclitaxel coated balloon

Active Comparator: Cohort A: Resolute™ Integrity Device: Cohort A: Resolute™ Integrity
Resolute™ Integrity are to be used in the trial
Other Name: 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




Primary Outcome Measures :
  1. In-segment percent diameter stenosis of the target lesion at 9 months after procedure [ Time Frame: 9 months after the procedure ]

Secondary Outcome Measures :
  1. Device success rate of the interventional therapy [ Time Frame: From the start of index procedure to the end of index procedure, Day 0 ]
    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

  2. Lesion success rate of the interventional therapy [ Time Frame: From the start of index procedure to the end of index procedure, Day 0 ]
    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.

  3. Clinical success rate of the interventional therapy [ Time Frame: 7 days after the procedure ]
    Without the occurrence of cardiac death, target vessel Myocardial Infarction (MI) or repeat target lesion revascularization (TLR).

  4. In-device percent diameter stenosis of the target lesion [ Time Frame: 9 months after the procedure ]
    Restenosis is defined as stenosis > 50% by angiography

  5. In-device minimal lumen diameter (MLD) [ Time Frame: 9 months after the procedure ]
  6. In-segment MLD [ Time Frame: 9 months after the procedure ]
  7. In-device late lumen loss (LLL) [ Time Frame: 9 months after the procedure ]
  8. In-segment LLL [ Time Frame: 9 months after the procedure ]
  9. Binary restenosis rate in lesion section [ Time Frame: 9 months after the procedure ]
  10. Target vessel revascularization (TVR) rate [ Time Frame: 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure ]
  11. Target lesion failure (TLF) rate [ Time Frame: 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure ]
  12. Target lesion revascularization (TLR) rate [ Time Frame: 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure ]
  13. Rate of all adverse events and severe adverse events [ Time Frame: 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure ]
  14. Rate of major adverse cardiovascular events [ Time Frame: 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure ]
    Including death, myocardial infarction (MI), stroke and renal failure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376646


Locations
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China
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing Hospital
Beijing, China
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University People's Hospital, Capital Medical University
Beijing, China
Xiangya Hospital of Central South University
Changsha, China
West China Hospital, Sichuan University
Chengdu, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, China
General Hospital of Daqing Oil Field
Daqing, 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
General Hospital of Ningxia Medical University
Yinchuan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Sponsors and Collaborators
DK Medical Technology (Suzhou) Co., Ltd.
Core Medical (Beijing) Co., Ltd.
Investigators
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Principal Investigator: Shubin Qiao Fuwai Hospital Chinese Academy of Medical Sciences
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Responsible Party: DK Medical Technology (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT03376646    
Other Study ID Numbers: CL-VP-02
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action