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Coronary Small Vessel DiseaseNCT03376646

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

A study testing Cohort A: Dissolve™, Cohort A: Resolute™ Integrity and Cohort B: Dissolve™-2.00mm in people with Coronary Small Vessel Disease, run by DK Medical Technology (Suzhou) Co., Ltd. at 15 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Small Vessel Disease
What is being tested?
Cohort A: Dissolve™, Cohort A: Resolute™ Integrity and Cohort B: Dissolve™-2.00mm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
277 participants
Where
15 sitesChina
Study dates
20 Jun 2018to 15 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

  • Beijing Hospital

    Beijing

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Peking University People's Hospital, Capital Medical University

    Beijing

  • Xiangya Hospital of Central South University

    Changsha

  • West China Hospital, Sichuan University

    Chengdu

  • The First Affiliated Hospital of Dalian Medical University

    Dalian

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian

  • General Hospital of Daqing Oil Field

    Daqing

  • Sir Run Run Shaw Hospital, Zhejiang University School of medicine

    Hangzhou

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

    Wuhan

  • General Hospital of Ningxia Medical University

    Yinchuan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

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

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.

Being tested
Cohort A: Dissolve™, Cohort A: Resolute™ Integrity, Cohort B: Dissolve™-2.00mm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cohort A: Dissolve™Device

    Also called Paclitaxel coated balloon

    Dissolve™ are to be used in the trial

  • Cohort A: Resolute™ IntegrityDevice

    Also called Zotarolimus eluting stent

    Resolute™ Integrity are to be used in the trial

  • Cohort B: Dissolve™-2.00mmDevice

    Dissolve™ are to be used in the trial

Study groups in NCT03376646
Study groupRoleWhat they receive
Cohort A: Dissolve™ExperimentalNot described
Receives: Device: Cohort A: Dissolve™
Cohort A: Resolute™ IntegrityActive comparatorNot described
Receives: Device: Cohort A: Resolute™ Integrity
Cohort B: Dissolve™-2.00mmExperimentalCohort B is single arm.
Receives: Device: Cohort B: Dissolve™-2.00mm

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 9 months after the procedure

Secondary outcomes (14)

  1. 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

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

  2. 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.

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

  3. Clinical success rate of the interventional therapy

    Without the occurrence of cardiac death, target vessel Myocardial Infarction (MI) or repeat target lesion revascularization (TLR).

    Measured: 7 days after the procedure

  4. In-device percent diameter stenosis of the target lesion

    Restenosis is defined as stenosis > 50% by angiography

    Measured: 9 months after the procedure

  5. In-device minimal lumen diameter (MLD)

    Measured: 9 months after the procedure

  6. In-segment MLD

    Measured: 9 months after the procedure

  7. In-device late lumen loss (LLL)

    Measured: 9 months after the procedure

  8. In-segment LLL

    Measured: 9 months after the procedure

  9. Binary restenosis rate in lesion section

    Measured: 9 months after the procedure

  10. Target vessel revascularization (TVR) rate

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Including death, myocardial infarction (MI), stroke and renal failure

    Measured: 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2017
  2. Study start20 Jun 2018
  3. Primary completion10 Jan 2020
  4. Study completion15 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03376646
Sponsor's protocol ID
CL-VP-02
Status last verified
Feb 2025
First submitted
8 Dec 2017
Last updated
20 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37995506

Questions about this trial

What is this clinical trial studying?

A study testing Cohort A: Dissolve™, Cohort A: Resolute™ Integrity and Cohort B: Dissolve™-2.00mm in people with Coronary Small Vessel Disease, run by DK Medical Technology (Suzhou) Co., Ltd. at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-segment percent diameter stenosis of the target lesion at 9 months after procedure (time frame: 9 months after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03376646, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.

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