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Coronary Artery DiseaseT-PNCT04951050

TARGET-PREMIER Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in CAS Treatment

A study testing Rapamycin target eluting stent in people with Coronary Artery Disease and Coronary Stenosis, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of the TARGET PREMIER trail in to demonstrate the safety and efficacy of the rapamycin target eluting stent in the treatment of subjects with ischemic heart disease (asymptomatic myocardial ischemia , table or unstable angina), with target lesion(s) in coronary arteries with visually estimated reference vessel… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, Coronary Stenosis
What is being tested?
Rapamycin target eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
28 Feb 2022to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Age ≥18 years.
  • Patient with an indication for percutaneous coronary intervention (PCI) including silent ischemia (in absence of symptoms a positive functional study or a reversible change in the ECG consistent with ischemia), angina (stable or unstable).
  • Subject acceptable candidate for coronary artery bypass surgery (CABG).
  • Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule.
  • Angiographic Inclusion Criteria:
  • Treatment up to two target lesions with a maximum of two lesions per epicardial vessel. If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 10mm apart per visual estimation.
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  • Target lesion(s) must be located in a native coronary artery with a visually estimated diameter stenosis ≥70%, TIMI 1, lesions length ≤36mm. Target vessel must be visually estimated diameter of ≥2.25mm to ≤4.0mm.
  • Target lesion must be adequately covered with a single stent.
  • Up to two target lesion needed treatment in one target vessel.
  • One non-target lesion is allowed prior to enrollment if successful. It should be located at the distal end of the target lesion, and be at lease 10mm apart, when both are in the same epicardial vessel.

Who cannot join

  • General Exclusion Criteria:
  • Acute myocardial infarction with 1 week or enzyme levels (Creatinkinase or Troponin) demonstrating that either or both enzyme levels have not returned to normal limits at the time of the procedure.
  • Target vessel (including branches) PCI within 12 months of the baseline procedure.
  • Known congestive heart failure (NYHA III) or left ventricular ejection fraction (LVEF) <30%
  • Patient has current unstable arrhythmias.
  • Patient has a history of any coronary arteries brachytherapy.
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  • Planned surgery within 6 months after index procedure.
  • Platelet count <100,000 cells/mm3 or >700,000 cells/mm3, white blood cell (WBC) count <3,000 cells/mm3.
  • Impaired renal function (serum creatinine >2.0mg/dl) or patient on dialysis.
  • Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attribute to cerebral vascular accident (CVA).
  • Patient has a history of bleeding diathesis, contraindication to dual antiplatelet therapy (DAPT).
  • Known allergy to protocol-required concomitant medications such as aspirin, or clopidogrel, or heparin and the study stent components such as cobalt, nickel, chromium, rapamycin or similar drugs.
  • Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint.
  • Other serious medical illness with life expectancy less than 1 year (e.g. cancer, congestive heart failure).
  • Patient has immunosuppressive or autoimmune disease, and is receiving or scheduled to immunosuppressive therapy.
  • A
  • Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test with on week before treatment.)
  • Women who intend to become pregnant with 12 months after the baseline procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the baseline procedure).
  • Patient has received an organ transplant or is on a waiting list for an organ transplant.
  • Patient is receiving or scheduled to receive chemotherapy or radiotherapy with 30 days before or any time after the baseline procedure.
  • Patient may not be obedient to the clinical investigation plan through the judgment by investigators.
  • Angiographic Inclusion Criteria:
  • Left main artery coronary disease.
  • Three-vessel coronary artery disease.
  • Target lesion is located in or supplied by an arterial or venous bypass graft.
  • In-stent restenosis lesions.
  • Patient has additional lesion(s) for which an intervention with 1 year after the index procedure would be required.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Meizhou Peple's Hospital

    Meizhou, Guangdong, 514000

Other trials in China

About this study

Official title: A Prospective, Multicenter, Single-arm Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in Patients With Coronary Artery Stenosis

The aim of the TARGET PREMIER trail in to demonstrate the safety and efficacy of the rapamycin target eluting stent in the treatment of subjects with ischemic heart disease (asymptomatic myocardial ischemia , table or unstable angina), with target lesion(s) in coronary arteries with visually estimated reference vessel diameter ≥2.25mm and ≤4.0 mm.

Read the detailed description

200 participants with coronary artery stenosis will enrolled in the investigation to receive PCI surgery treatment with rapamycin target eluting stent implantation. All the participants will get clinical follow-up after PCI surgery within 30 days, 6 months, 9 months, 12 months and 2-5 years, and they will be conducted coronary angiogram at 9th month after PCI to get the data of in-stent late loss which was the main endpoint of the investigation. The secondary endpoints including device sucess, operation success, clinical sucess, Doce, PoCE, TLR, TVR, MI incident rate, death, stent thrombosis as defined by ARC, stent retraction, MLD, DS and ARB. The data derived from the investigation will be performed statistic analysis to evaluate whether the clinical outcome meet the PG.

Being tested
Rapamycin target eluting stent
Medical subject headings
Coronary Artery Disease, Coronary Stenosis

What participants receive

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

  • Rapamycin target eluting stentDevice

    Rapamycin target eluting stent

Study groups in NCT04951050
Study groupRoleWhat they receive
Drug eluting stentExperimentalNot described
Receives: Device: Rapamycin target eluting stent

What is being measured

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

  1. In-stent late loss

    In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)

    Measured: 9 months

Secondary outcomes (15)

  1. Target Lesion Failure

    Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated)

    Measured: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years

  2. Any myocardial ischemia (MI)

    percentage of participants that had any MI

    Measured: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years

  3. Any revascularization

    percentage of participants that had any revascularization

    Measured: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years

  4. Ischemia-driven TLR

    percentage of participants that had Ischemia-driven TLR

    Measured: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years

  5. Probable and definite stent thrombosis defined by Academic Research Consortium (ARC)

    percentage of participants that had probable and definite stent thrombosis

    Measured: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years

  6. Late lumen loss in segment

    Late Lumen Loss in segment at 9 months post-procedure as measured by quantitative coronary angiography (QCA)

    Measured: 9 months

  7. In-stent and in-segment binary restenosis rate

    percentage of restenosis ≥50% in-stent or in-segment at 9 months post-procedure

    Measured: 9 months

  8. Device success

    Device Success is defined as a final residual diameter stenosis of <30%, thrombolysis in myocardial infarction (TIMI) 3, by QCA, using the assigned device only

    Measured: 0 day

  9. Procedure success

    Procedure Success defined as achievement of a final diameter stenosis of <30%, TIMI 3, by QCA, using any percutaneous method, without the occurrence of death, Q-wave or non-Q-wave MI, or repeat revascularization of the target lesion during the hospital stay.

    Measured: During the hospital stay to a maximum of the first seven days post index procedure

  10. Target lesion success

    Target lesion success defined as achievement of a final diameter stenosis of <30%, TIMI 3, by QCA, using any percutaneous method.

    Measured: 0 day

  11. TLR

    Including ischemia driven or non-ischemia driven

    Measured: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years

  12. target vessel revascularization (TVR)

    Including ischemia driven or non-ischemia driven

    Measured: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years

  13. Patient oriented composite endpoint (PoCE)

    defined as all death, all MI and any revascularization

    Measured: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years

  14. In-stent and in-segment %diameter stenosis (%DS)

    In-stent and in-segment %diameter stenosis (%DS) at 9 months post-procedure as measured by QCA

    Measured: 9 months

  15. In-stent and in-segment minimum lumen diameter

    In-stent and in-segment minimum lumen diameter at 9 months post-procedure as measured by QCA.

    Measured: 9 months

Timeline

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

  1. First posted6 Jul 2021
  2. Study start28 Feb 2022
  3. Primary completion26 Aug 2023
  4. Study completion31 Dec 2027 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04951050
Sponsor's protocol ID
D-IC-035
Acronym
T-P
Status last verified
Nov 2023
First submitted
26 Jun 2021
Last updated
9 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Rapamycin target eluting stent in people with Coronary Artery Disease and Coronary Stenosis, run by Shanghai MicroPort Medical (Group) Co., Ltd. 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 10 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 9 Nov 2023. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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-stent late 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 NCT04951050.

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 9 Nov 2023.

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