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Coronary In-stent RestenosisPhase 2/3NCT04213378

Evaluation of the Efficacy and Safety of a Paclitaxel Eluting PTCA Balloon Catheter in Coronary In-stent Restenosis

A Phase 2/3 study testing Paclitaxel eluting PTCA balloon and SeQuent® Please paclitaxel eluting balloon in people with Coronary In-stent Restenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Over the past two decades, stents implantation has developed as a standard treatment for coronary stenosis lesions. However, int-stent restenosis (ISR) was one of the main factors affecting the long-term efficacy of coronary artery interventional therapy, with the incidence of ISR after percutaneous coronary… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary In-stent Restenosis
What is being tested?
Paclitaxel eluting PTCA balloon and SeQuent® Please paclitaxel eluting balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
1 siteChina
Study dates
1 Jan 2017to 31 Dec 2020
Phase
Phase 2/3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients oriented
  • Patients with age between 18 and 80 years old (including 18 and 80 years old);
  • Patients with stable angina, or unstable angina pectoris, or old myocardial infarction (MI) or with evidence of local myocardial ischemia although without symptoms;
  • Patients with restenosis after the first time stent implantation of de novo coronary lesions (i.e., no other surgical treatments for the target lesions except for the first stent implantation);
  • Patients with the willing to receive their own coronary angioplasty;
  • Patients with LVEF>30% measured within 30 days before recruitment;
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  • Patients agree to receive 9-month angiography follow-up, and agree to receive 30 days, 6 months, 12 months clinical follow-up;
  • Patients at the age of childbirth must take effective contraception measures until the study is completed since they are chosen into screening period;
  • Patients agree to take part in the trial and sign the informed consent.
  • Lesions oriented (Visual estimation)
  • Patients with Mehran type I, type II and type III in-stent restenosis (ISR);
  • Reference vascular diameter between 2.0-4.0 mm (including 2.0 and 4.0 mm), length<30mm;
  • The percent of lumen ISR ≥70%, or ≥50% with local ischemia evidence before interventional surgery;
  • Patients with residual stenosis ≤30%, and ≤ type B dissection post pretreatment;
  • Distance between other lesions that require treatment and target lesions >10 mm;
  • Patients with coronary artery anatomy allowing delivery of research device to target lesions.

Who cannot join

  • Patients oriented
  • Subjects with consistent clinical symptoms and/or ECG changes and/or cardiac enzymes changes with MI (including STEMI and Non-STEMI) within one week;
  • Subjects with cardiac shock, hemodynamic instability or refractory ventricular arrhythmia that require positive inotropic drugs or mechanical circulation support;
  • Subjects with one of following conditions (from screening period to the day of operation): (1) life expectancy is less than 1 year because of other severe diseases (like cancer), (2) drug abuse at present (like alcohol, cocaine, heroin and so on), (3) plan to accept surgery that may cause the programs not to be complied with or confusing with data understanding;
  • Subjects with bleeding diathesis or active gastrointestinal ulcers, or stroke/transient ischemic attack within 3 months;
  • Subjects with severe congestive heart failure or severe heart failure at the level of NYHA IV;
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  • Subjects are receiving dialysis or baseline serum creatinine levels>2.0 mg/dL(177μmol/L);
  • Subjects with severe valvular heart disease;
  • Subjects who have been or are scheduled for a heart transplantation during the trial;
  • Subjects who have been pregnant or is planning to be pregnant or is breastfeeding during the trial;
  • Subjects who are participating in any other clinical trial;
  • Researchers don't think they're suitable for the trial because of other reasons;
  • Lesions oriented (Visual estimation)
  • Total occlusion with TIMI 0 (Mehran IV stenosis);
  • With the evidence of widespread thrombi in the target vessels prior to intervention;
  • Planning to treat >3 lesions (i.e., up to 3 target lesions);
  • Planning to treat >2 major epicardial vessels (i.e., up to 2 target lesions);
  • Planning to treat a single lesions with more than 1 balloon;
  • Planning to treat a true bifurcation lesion with double stents technique;
  • Left main lesions.
  • Combined medication oriented
  • Subjects known to intolerant to dual antiplatelet therapy for 3 months post interventional treatment (e.g., aspirin and/or ticagrelor and/or clopidogrel);
  • Subjects with leukopenia (WBC<3x10^9/L for more than 3 days) or neutropenia (NEUT<1x10^9/L for more than 3 days) or a history of platelet reduction (PLT 30x10^9/L);
  • Subjects known to be intolerant or allergic to paclitaxel.

Trial locations and contacts

1 site in 1 country.

Jun Jiang, MD, PhD contact

+86-13588706891

2106002@zju.edu.cn

Jian-an Wang, MD, PhD contact

+86-13805786328

wja@zju.edu.cn

China1 site, 1 recruiting

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310009

    Jun Jiang, MD, PhD, +86-13588706891, 2106002@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Evaluation of the Efficacy and Safety of a Paclitaxel Eluting PTCA Balloon Catheter in Coronary In-stent Restenosis: a Randomized, Open-label, Positive Parallel Controlled, Multicenter Clinical Trial

Over the past two decades, stents implantation has developed as a standard treatment for coronary stenosis lesions. However, int-stent restenosis (ISR) was one of the main factors affecting the long-term efficacy of coronary artery interventional therapy, with the incidence of ISR after percutaneous coronary intervention ranging from 5% to 35%. At present, there are three main means for ISR: (1) simple balloon dilation; 2) intravascular radiotherapy; and (3) drug elution stent. But the results are still not ideal. Drug coated balloon (DCB) is a new method that may be used to treat ISR in recent years. In the PEPCAD II study, when dealing with ISR, the paclitaxel eluting balloon (PEB) SeQuent® Please significantly reduced the major adverse cardiovascular events (MACEs) compared to the paclitaxel eluting stent (PES) TAXUS Liberte. In ISR-I and ISR-II trial, it was found that compared with uncoated PTCA balloons, PEB could significantly inhibit endothelial hyperplasia and significantly reduce MACEs treating ISR. The purpose of this study was to assess the efficacy and safety of a Chinese-developed PEB in treatment of coronary ISR compared to SeQuent® Please PEB.

Being tested
Paclitaxel eluting PTCA balloon, SeQuent® Please paclitaxel eluting balloon

What participants receive

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

  • Paclitaxel eluting PTCA balloonDevice

    Treatment of coronary in-stent re-stenosis with paclitaxel eluting PTCA balloon

  • SeQuent® Please paclitaxel eluting balloonDevice

    Treatment of coronary in-stent re-stenosis with SeQuent® Please paclitaxel eluting balloon

Study groups in NCT04213378
Study groupRoleWhat they receive
Paclitaxel eluting PTCA balloonExperimentalTreatment of coronary in-stent restenosis with paclitaxel eluting PTCA balloon
Receives: Device: Paclitaxel eluting PTCA balloon
SeQuent® Please paclitaxel eluting balloonActive comparatorTreatment of coronary in-stent restenosis with SeQuent® Please paclitaxel eluting balloon
Receives: Device: SeQuent® Please paclitaxel eluting balloon

What is being measured

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

  1. Rate of target lesion late lumen loss

    Measured: 9 months

Secondary outcomes (5)

  1. Rate of interventional therapy success

    Including rate of device success, rate of disease success and rate of clinical success

    Measured: 0-24 hours, 30 days, 6 months, 9 months, 12 months

  2. Rate of target lesion restenosis

    Measured: 9 months

  3. Device-oriented composite clinical cardiovascular outcomes

    Cardiac death, target vessel-related myocardial infarction, symptoms-driven target lesion revascularization

    Measured: 30 days, 6 months, 9 months, 12 months

  4. Patient-oriented composite clinical cardiovascular outcomes

    All-cause mortality, all myocardial infarction, all revascularization

    Measured: 30 days, 6 months, 9 months, 12 months

  5. Rate of ARC defined thrombosis events

    All definite, probable and possible thrombosis in acute, subacute and late stage

    Measured: 0-24 hours, 30 days, 6 months, 9 months, 12 months

Timeline

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

  1. First posted30 Dec 2019
  2. Study start1 Jan 2017
  3. Primary completion31 Jan 2020 (estimated)
  4. Study completion31 Dec 2020 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04213378
Sponsor's protocol ID
SAHZJU CT016
Status last verified
Dec 2019
First submitted
24 Dec 2019
Last updated
30 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Xue W, Ma J, Yu X, Ruan Z, Sun Y, Wu T, Zhang X, Wu L. Analysis of the incidence and influencing factors associated with binary restenosis of target lesions after drug-coated balloon angioplasty for patients with in-stent restenosis. BMC Cardiovasc Disord. 2022 Nov 20;22(1):493. doi: 10.1186/s12872-022-02923-z.

    PubMed 36404303

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Paclitaxel eluting PTCA balloon and SeQuent® Please paclitaxel eluting balloon in people with Coronary In-stent Restenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 16 inclusion and 24 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 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Jun Jiang, MD, PhD (+86-13588706891, 2106002@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of target lesion late lumen loss (time frame: 9 months). 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 NCT04213378, 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 30 Dec 2019.

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