Study on Absorbable Zinc Alloy Drug Eluting Coronary Stent System

NCT05477940 | Unknown

• 1 other identifier: 2021-R-1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Heart Disease; Drug Eluting Stent

Outcome Measures

Primary Outcomes (5)

• late lumen loss

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

  6 months after operation

• 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

  6 months after operation

• 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

  6 months after operation

• 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

  1 months after operation

• 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

  1 months after operation

Secondary Outcomes (5)

• Device success rate

  in the operation

• Operation Success Rate

  0 to 24 hours after intervention

• Thrombotic events incidence

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

• incidence of target lumen failure(TLF)

  3, 9,12 months after operation

• incidence of major adverse cardiac events(MACE)

  3, 9,12 months after operation

Study Arms (1)

Absorbable zinc alloy drug eluting stent system

EXPERIMENTAL

1. 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%.

Device: Absorbable zinc alloy drug eluting coronary stent system

Interventions

Absorbable zinc alloy drug eluting coronary stent system DEVICE

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

Absorbable zinc alloy drug eluting stent system

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Shandong Branden Med.Device Co.,Ltd: lead
• Shandong Rientech Medical Tech Co., Ltd.: collaborator

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: July 28, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share