AzTrials
AzTrials

Coronary Heart DiseaseNCT05477940

Study on Absorbable Zinc Alloy Drug Eluting Coronary Stent System

A study testing Absorbable zinc alloy drug eluting coronary stent system in people with Coronary Heart Disease and Drug Eluting Stent, run by Shandong Branden Med.Device 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

This trial is a prospective, two center single group registration pilot trial aiming to evaluate the product safety, and provide information for the later confirmatory test design according to the results. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Heart Disease, Drug Eluting Stent
What is being tested?
Absorbable zinc alloy drug eluting coronary stent system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Sep 2022to 1 Sep 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (1) General inclusion criteria
  • The patient must be 18-75 years old; ② The patient has evidence of ischemia (such as chest pain or functional examination such as stress test, which determines that he has stable or unstable angina pectoris or asymptomatic myocardial ischemia) and is suitable for elective PCI;
  • The patient must be a qualified candidate for PCI; ④ Female patients of childbearing age had no pregnancy plan for up to one year after the starting operation. Women of childbearing age must have a pregnancy test and get negative results according to the regulations of the local test center 14 days before the starting operation.
  • Female patients were not breast-feeding during the screening visit and had no breast-feeding plan for up to 1 year after the starting operation; ⑥ The patient agrees not to participate in other clinical trials until the end point of this trial is reached; ⑦ The patient / legally authorized representative understands the purpose and procedure of the test and voluntarily signs the informed consent form;

Who cannot join

  • ① Cardiogenic shock;
  • It is known that the left ventricular ejection fraction (LVEF) measured by quantitative analysis is less than 30%. For patients with stable coronary heart disease, LVEF measured within 6 months before operation is effective. For patients with acute coronary syndrome (ACS), LVEF must be measured before randomization to determine whether the patients meet the conditions;
  • The patient has a high risk of bleeding, or has a history of bleeding tendency and coagulation disorder; Major gastrointestinal bleeding within 6 months; Severe hematuria; There are contraindications to antiplatelet preparation and anticoagulant treatment, and antithrombotic treatment cannot be carried out;
  • Patients have allergic / hypersensitive reactions to aspirin, clopidogrel, heparin and ticlopidine hydrochloride (platelet inhibitor);
  • Patients have allergies or contraindications that inhibit the device materials and degradation products (rapamycin, polyglycolide and lactide) and cannot be completely cured before treatment.
  • The patient is allergic to contrast medium and cannot be completely cured before treatment.
Show all 37Show fewer
  • Any surgical treatment requiring general anesthesia or interruption of aspirin or P2Y12 inhibitors is planned within 365 days after operation.
  • The patient received target vessel PCI within 365 days before operation. If the patient has received non target vessel PCI Treatment > 30 days before operation, the patient can still be enrolled in this trial.
  • Patients expected to require staged PCI of target vessels.
  • Acute myocardial infarction within one week; A series of clinical symptoms of the patient are consistent with new acute myocardial infarction (AMI).
  • During screening, the patient was determined to have arrhythmia according to any of the following criteria; Patient a needs coumarin or any other long-term oral anticoagulant; B patient may have hemodynamic instability due to arrhythmia; Patients with C had poor survival and prognosis due to arrhythmia;
  • The patient had severe peripheral vascular disease and could not be safely inserted with 6F sheath;
  • Stroke (CVA) or transient ischemic attack (TIA) occurred in the past 6 months; Intracranial hemorrhage, permanent neurological deficit, or any known intracranial lesions (such as aneurysms, arteriovenous malformations, etc.) have occurred in the past
  • ⑭ Major surgery within six weeks;
  • ⑮ Leukocyte count < 4.0 109cells / L and platelet count < 100 109cells / L;
  • ⑯ Severe renal and liver dysfunction;
  • ⑰ The life expectancy of patients is less than 12 months;
  • ⑱ The patient is receiving immunosuppressive therapy or is known to have immunosuppressive or autoimmune diseases (such as human immunodeficiency virus infection, systemic lupus erythematosus, etc.); Note: immunotherapy does not include hormone therapy;
  • ⑲ Patients who participate in clinical trials of other drugs or devices and fail to reach the main end point of the study;
  • ⑳ Patients who are unable or unwilling to participate in this trial, and the researchers believe that they are not suitable to participate in this trial.
  • 8.2 angiographic exclusion criteria
  • The target lesion is located in the left main trunk and more than one lesion (not a single target lesion);
  • The% ds of visual or quantitative evaluation of target lesions is less than 50%, and the blood flow TIMI is less than grade 1.
  • The Dmax of target lesions measured by online QCA exceeds the range of 2.5mm-3.53.5mm, or the RVD measured by visual inspection exceeds the range of 2.5mm-3.53.5mm.
  • The visual length of target lesion or the length measured by online QCA is not within the range of ≤ 28 ≤ 28mm.
  • The target lesion of the right coronary artery (RCA) at the aortic opening (within 3mm of the aortic junction of RCA);
  • The target lesion is located within 3mm from the starting point of left anterior descending artery (LAD) or left circumflex artery (LCX).
  • The target lesion involves bifurcation and has the following characteristics:
  • A side branch diameter ≥ 2mm; B diameter stenosis ≥ 50%; The C lateral branch needs to use protective guide wire or the lateral branch needs to be pre expanded.
  • Anatomical structures near or within the target lesion hinder the delivery of zinc alloy stents, including:
  • A extreme reverse arch (≥ 90 °) at the proximal end of the target lesion or within the lesion; B. excessive bending of the proximal end of the target lesion or within the lesion (≥ two 45 ° angles); C moderate or severe calcification near or inside the target lesion.
  • The target lesion or target vessel involves myocardial bridge;
  • Angiographic images showed that the target vessel contained thrombus;
  • Before the starting operation, the target vessel has been treated with stent, and the zinc alloy stent will need to pass through the stent to reach the target lesion;
  • The target vessel has been treated with stent, and the target lesion is located within 5mm of the proximal end of the treated lesion;
  • The pre dilated balloon could not expand completely at the target lesion. Full expansion is based on the following criteria:
  • the stenosis rate (% DS) of participating lesion diameter must be < 40% (visual inspection); B blood flow reaches timi3 (visual inspection); C no angiographic complications (e.g. distal embolization, collateral occlusion); D no interlayer, NHLBI grade, d-f type; E no persistent chest pain (> 5 minutes) and no ST segment depression or elevation lasting > 5 minutes.

About this study

Official title: Exploratory Study on the Safety and Effectiveness of Absorbable Zinc Alloy Drug-eluting Coronary Stent System

This trial is a prospective, two center single group registration pilot trial aiming to evaluate the product safety, and provide information for the later confirmatory test design according to the results.

Read the detailed description

This trial is a prospective, two center single group registration pilot trial with late lumen loss in stent (LLL), mace event and target lesion failure (TLF) as the main endpoint. Subjects were followed up clinically or by telephone at 1 month, 3 months, 6 months, 9 months and 12 months, and coronary angiography was performed at the target lesion segments for 6 months to calculate lumen loss. Analyze and evaluate the collected data, preliminarily evaluate the product safety, and provide information for the later confirmatory test design according to the results.

Being tested
Absorbable zinc alloy drug eluting coronary stent system
Medical subject headings
Coronary Disease

What participants receive

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

  • Absorbable zinc alloy drug eluting coronary stent systemDevice

    Absorbable zinc alloy drug eluting coronary stent system" (hereinafter referred to as "stent system") consists of "delivery system" and "drug stent (hereinafter referred to as stent)" pressed on the balloon end of the delivery system

Study groups in NCT05477940
Study groupRoleWhat they receive
Absorbable zinc alloy drug eluting stent systemExperimental1. Balloon pre dilation is required. 2. Inject nitroglycerin, perform angiography after stent implantation, and record the specification and model of the instrument. 3. After stent expansion, it should reach 100% - 110% of the vessel diameter, and the visual residual stenosis should be less than 20%.
Receives: Device: Absorbable zinc alloy drug eluting coronary stent system

What is being measured

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

  1. late lumen loss

    Difference between the minimum lumen diameter immediately after operation and the minimum lumen diameter 6 months after operation

    Measured: 6 months after operation

  2. incidence of target lumen failure(TLF)

    proportion of the number of patients with cardiac death, target vessel myocardial infarction, or clinical symptom driven target vessel revascularization in the total number

    Measured: 6 months after operation

  3. incidence of major adverse cardiac events(MACE)

    proportion of the number of patients with cardiac death, myocardial infarction or target lesion revascularization (TLR) in the total number

    Measured: 6 months after operation

  4. incidence of target lumen failure(TLF)

    proportion of the number of patients with cardiac death, target vessel myocardial infarction, or clinical symptom driven target vessel revascularization in the total number

    Measured: 1 months after operation

  5. incidence of major adverse cardiac events(MACE)

    proportion of the number of patients with cardiac death, myocardial infarction or target lesion revascularization (TLR) in the total number

    Measured: 1 months after operation

Secondary outcomes (5)

  1. Device success rate

    It means that the instrument can be successfully delivered to the target lesion as expected, the stent can be expanded normally, and the catheter can be successfully withdrawn to the outside of the body.

    Measured: in the operation

  2. Operation Success Rate

    After stent implantation, stent diameter stenosis < 30% (visual), TIMI flow class 3, and hospitalization MACE events did not happen

    Measured: 0 to 24 hours after intervention

  3. Thrombotic events incidence

    According to ARC definition it includes deterministic thrombosis, possible thrombosis and not eliminating thrombosis; point-in-time include acute within 24h, subacute between 2 and 30 d and later period over 30 d

    Measured: 1, 3, 6, 9 and 12 months after operation

  4. incidence of target lumen failure(TLF)

    proportion of the number of patients with cardiac death, target vessel myocardial infarction, or clinical symptom driven target vessel revascularization in the total number

    Measured: 3, 9,12 months after operation

  5. incidence of major adverse cardiac events(MACE)

    proportion of the number of patients with cardiac death, myocardial infarction or target lesion revascularization (TLR) in the total number

    Measured: 3, 9,12 months after operation

Timeline

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

  1. First posted28 Jul 2022
  2. Study start1 Sep 2022 (estimated)
  3. Primary completion1 Sep 2023 (estimated)
  4. Study completion1 Sep 2024 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05477940
Sponsor's protocol ID
2021-R-1
Status last verified
Jul 2022
First submitted
26 Apr 2022
Last updated
28 Jul 2022
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 Absorbable zinc alloy drug eluting coronary stent system in people with Coronary Heart Disease and Drug Eluting Stent, run by Shandong Branden Med.Device 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 4 inclusion and 37 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 28 Jul 2022. 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?

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?

late lumen loss (time frame: 6 months after operation). The study lists 5 primary outcomes in all. 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 NCT05477940.

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 28 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in