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AzTrials

Coronary Artery In-stent RestenosisNCT04386213

Trial for MicroPort's DCB

A study testing coronary artery in-stent restenosis in people with Coronary Artery In-stent Restenosis, run by Shanghai MicroPort Medical (Group) Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a multicenter, randomized, controlled clinical research and aims to evaluate the safety and efficacy of the paclitaxel drug-coated coronary artery balloon catheter in patients with coronary artery in-stent restenosis compared to seQuent® please paclitaxel drug-coated coronary artery balloon catheter. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Artery In-stent Restenosis
What is being tested?
coronary artery in-stent restenosis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
No sites listed yet
Study dates
1 Sep 2020to 31 Jul 2025
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria:
  • 1.18-75 years of age, males or non-pregnant females; 2.With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction; 3.Restenosis after the first stent implantation, and more than 90 days after the stent implantation; 4.Patients with indications for coronary artery bypass graft surgery; 5.To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
  • Angiographic Inclusion Criteria:
  • One or two target lesions;
  • Restenosis in the stent (including bare stent, permanent coating and biodegradable coating) : Mehran I, II and III stenosis;The diameter of the reference vessel ranges from 2.0mm to 4.0mm, and the length ≤40mm;
  • The original stent diameter stenosis before surgery must be ≥70% or ≥50% with local ischemia;
  • There should be no more than two lesions requiring interventional treatment, and the distance between the two lesions must be >10mm.

Who cannot join

  • General Exclusion Criteria:
  • Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
  • Severe congestive heart failure (NYHA III and above) ,or left ventricular ejection fraction <30% (ultrasound or left ventricular angiography);
  • The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia;
  • Blood test prompted platelet counts of less than 100x10E9/L or greater than 700x10E9/L, white blood cells than 3x10E9/L; which was judged to be clinically significant by the researchers;
  • Preoperative renal function serum creatinine >2.0mg/DL; receiving hemodialysis;
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  • Subjects with bleeding tendency, antiplatelet preparation and anticoagulant treatment contraindications, subjects unable to receive antithrombotic treatment, or subjects unable to tolerate DAPT treatment for three months;
  • Previous history of peptic ulcer or gastrointestinal bleeding within 6 months;
  • Patients with cerebral vascular accident or transient ischemic attack (TIA) within the previous 6 months, or with permanent neurological defects that may lead to non-compliance with the protocol;
  • Allergic to aspirin, heparin, contrast agent, polylactic acid polymer and paclitaxel;
  • The life expectancy of the subjects is less than 12 months;
  • The researcher judged that the subjects had poor compliance and could not complete the study as required;Or for other reasons that the researchers consider inappropriate;
  • Subjects who are participating in any other clinical trial, or who have participated in clinical trials of other drugs or medical devices before being enrolled and have not reached the main study endpoint;
  • Pregnant or breast-feeding female subjects (women who may be pregnant must undergo a pregnancy test 7 days prior to baseline surgery).
  • Angiographic Exclusion Criteria:
  • In-stent restenosis without successful predilatation;
  • Stent restenosis of vein grafts;
  • Bridge stent restenosis;
  • All three vessels were diseased and needed revascularization;
  • Vessel diameter of branch opening in bifurcation lesions ≥2.5mm;
  • Complete occlusion of blood flow at TIMI level 0 (Mehran type IV stenosis);
  • The lesion was located in the left trunk and within 2mm from the opening.

Trial locations and contacts

No sites are listed yet.

Ling Tao contact

13636498543

clfeng@microport.com

Ling Tao contact

029-84775507

webmaster@fmmu.edu.cn

About this study

Official title: A Prospective, Multicenter, Randomized Trial in Evaluating the Safety and Efficacy of the Paclitaxel Drug-coated Coronary Artery Balloon Catheter in Patients With Coronary Artery In-stent Restenosis Compared to SeQuent® Please Paclitaxel Drug-coated Coronary Artery Balloon Catheter

This study is a multicenter, randomized, controlled clinical research and aims to evaluate the safety and efficacy of the paclitaxel drug-coated coronary artery balloon catheter in patients with coronary artery in-stent restenosis compared to seQuent® please paclitaxel drug-coated coronary artery balloon catheter.

Read the detailed description

This prospective, multicenter, randomized controlled clinical study is designed to enroll 216 subjects with in-stent restenosis and randomly assign them to the trial and control groups on a 1:1 basis.The experimental group was treated with paclitaxel drug-coated coronary artery balloon catheter, and the control group was treated with SeQuent ® Please paclitaxel balloon catheter, which has been marketed. In-segment late lumen loss 9 months after surgery was the main end point of the study. All subjects were followed up clinically at 1 month, 6 months, 9 months, 1 year and 2 years after the surgery, and were followed up with angiography at 9 months after the surgery.

Being tested
coronary artery in-stent restenosis

What participants receive

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

  • coronary artery in-stent restenosisDevice

    treat the petients with coronary artery in-stent restenosis

Study groups in NCT04386213
Study groupRoleWhat they receive
Paclitaxel Drug-coated BalloonExperimentalNot described
Receives: Device: coronary artery in-stent restenosis
SeQuent® Please Paclitaxel Drug-coated BalloonActive comparatorNot described
Receives: Device: coronary artery in-stent restenosis

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

    Measured: 9 months after coronary angiography

Secondary outcomes (12)

  1. Device success

    defined as residual stenosis ≤30% and TIMI3 blood flow after drug-eluting balloon dilation.

    Measured: during the procedure

  2. Procedural success

    Defined as target lesions with residual stenosis ≤30% and TIMI3 blood flow after any interventional treatment, without thrombus or dissection need interention.

    Measured: Immediately after the index procedure

  3. Clinical success

    Defined as the absence of device-related composite endpoint events during hospitalization (up to 7 days after surgery) on the basis of procedural success.

    Measured: At time of procedure up to 7 days in hospital

  4. Device-oriented composite endpoints (Target Lesion Failure)

    TLF is defined as the composited endpoints of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization.

    Measured: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure

  5. Patient-oriented composite endpoint (PoCE)

    Patient-oriented composite endpoint is defined as all cause death, all myocardial infarction, and any revascularization.

    Measured: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure

  6. Death (Cardiac, Non-cardiac)

    Defined as death due to the following causes. Acute myocardial infarction; cardiac perforation/cardiac tamponade; arrhythmia or abnormal conduction; death due to surgical complications, including bleeding, vascular repair, transfusion response, or coronary artery bypass surgery; anything that does not rule out death from cardiac causes.

    Non-cardiac death: defined as death from causes other than the above cardiac causes.

    Measured: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure

  7. The number and rate of Myocardial Infarction (MI)

    Attributable to target vessel (TV-MI), Not attributable to target vessel (NTV-MI)

    Measured: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure

  8. The number and rate of Target Lesion Revascularization (TLR)

    Ischemia-driven TLR (ID-TLR), Not ischemia-driven TLR (NID-TLR)

    Measured: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure

  9. The number and rate of Target Vessel Revascularization (TVR)

    Ischemia-driven TVR (ID-TVR), Not ischemia-driven TVR (NID-TVR)

    Measured: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure

  10. The number and rate of Any Revascularization

    Ischemia-driven , Not ischemia-driven

    Measured: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure

  11. The number and rate of Thrombosis (per ARC definition)

    Timing (acute, sub-acute, late and very late) Evidence (Definite and Probable)

    Measured: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure

  12. In-segment angiography binary restenosis (ABR, %)

    Defined as the proportion of subjects with restenosis occurring in the target lesion segment and the diameter stenosis ≥50%.Quantitative coronary angiography analysis (QCA) calculation (1- 9 months after the operation of the original stent restenosis in-segment residual minimum lumen diameter / reference vessel diameter) ×100%

    Measured: 9 months after index procedure

Timeline

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

  1. First posted13 May 2020
  2. Study start1 Sep 2020 (estimated)
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion31 Jul 2025 (estimated)

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
Single blind
Who is masked
Participant
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04386213
Sponsor's protocol ID
PROMISE-DCB
Status last verified
May 2020
First submitted
6 May 2020
Last updated
13 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing coronary artery in-stent restenosis in people with Coronary Artery In-stent Restenosis, run by Shanghai MicroPort Medical (Group) Co., Ltd..

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 7 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Ling Tao (13636498543, clfeng@microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-segment Late Lumen Loss (time frame: 9 months after coronary angiography). 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 NCT04386213.

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 13 May 2020.

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