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Coronary In-stent RestenosisNCT03373695

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

A study testing Dissolve™ and SeQuent®Please in people with Coronary In-stent Restenosis, 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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary In-stent Restenosis
What is being tested?
Dissolve™ and SeQuent®Please
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
15 sitesChina
Study dates
22 Feb 2018to 24 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:
  • 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:
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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
  • Lesion which cannot be treated by percutaneous transluminal coronary angioplasty (PTCA) or percutaneous intervention (PCI)
  • Reference vessel diameter < 2.0mm
  • Patients with multiple lesions (≥ 3) requiring percutaneous coronary intervention treatment in the same artery
  • 3-vessel disease that all need to be intervened
  • The diameter of the branch lesions in the target lesion ≥ 2.5mm
  • LM lesions and Ostial lesion within 5mm to the root aorta
  • Non-target lesion was not intervened successfully before target lesions being intervened
  • Related to concomitant therapy:
  • Patients cannot tolerate aspirin and/or clopidogrel and or tricagrelor, patients with the history of neutrocytopenia or thrombocytopenia, or patients with severe hypohepatia and prohibited to take clopidogrel
  • Patients known allergic to paclitaxel
  • Patients known allergic to contrast materials

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

  • The First Affiliated Hospital of Zhengzhou University

    Hangzhou

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

    Wuhan

  • General Hospital of Ningxia Medical University

    Yinchuan

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 SeQuent® Please in Treatment of Coronary In-stent Restenosis in Chinese Population

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.

Being tested
Dissolve™, SeQuent®Please

What participants receive

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

  • Dissolve™Device

    Dissolve™ are to be used in the trial

  • SeQuent®PleaseDevice

    SeQuent®Please are to be used in the trial

Study groups in NCT03373695
Study groupRoleWhat they receive
Dissolve™ExperimentalNot described
Receives: Device: Dissolve™
SeQuent®PleaseActive comparatorNot described
Receives: Device: SeQuent®Please

What is being measured

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

  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.

    Measured: From the end of procedure to 9 months after the procedure

Secondary outcomes (9)

  1. Device success rate of the interventional therapy

    Successful delivery and use of the assigned balloon at the intended target lesion and successful withdrawal of the delivery system with attainment of final residual stenosis of less than 30% and TIMI 3 blood flow by visual estimation.

    Measured: From the start of index procedure to end of index procedure

  2. Lesion success rate of the interventional therapy

    Attainment of final residual stenosis of target lesion less than 30% and TIMI 3 blood flow by visual estimation.

    Measured: From the start of index procedure to end of index procedure

  3. Clinical success rate of the interventional therapy

    Achievement of final residual stenosis of less than 30% by visual estimation with successful delivery and use of assigned balloon at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel Myocardial Infarction (MI) or repeat Target lesion revascularization (TLR).

    Measured: 7 days after the procedure

  4. Rate of restenosis in the target lesions

    Restenosis is defined as stenosis > 30% by angiography

    Measured: 9 months after the procedure

  5. TLR rate

    Measured: 9 months after the procedure

  6. Target vessel revascularization (TVR) rate

    Measured: 9 months after the procedure

  7. Target lesion failure (TLF) rate

    Measured: 9 months after the procedure

  8. Rate of major adverse cardiovascular events

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

  9. 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

Timeline

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

  1. First posted14 Dec 2017
  2. Study start22 Feb 2018
  3. Primary completion9 Jan 2020
  4. Study completion24 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
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03373695
Sponsor's protocol ID
CL-VP-01
Status last verified
Feb 2025
First submitted
5 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 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.

    PubMed 37045496

Questions about this trial

What is this clinical trial studying?

A study testing Dissolve™ and SeQuent®Please in people with Coronary In-stent Restenosis, 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 11 inclusion and 26 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 Late Lumen Loss (time frame: From the end of procedure to 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 NCT03373695, 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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