None listed
Conditions
Interventions
Medical Device : Patients with peripheral artery disease are randomly assigned and divided into a test group medical device(Genoss DCB) and a control medical device(IN.PACT Admiral DCB) at a ratio of
Sponsors
GENOSS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 19 years old and under 85 years old 2. A person with a Rutherford classification of 2 to 4 * Rutherford classification - 0 : Asymptomatic - 1 : Mild claudication - 2 : Moderate claudication - 3 : Severe claudication - 4 : Ischemic rest pain - 5 : Minor tissue loss - 6 : Major tissue loss 3. The target lesion is located in the Superficial femoral artery or Popliteal artery 4. Those with a reference vessel diameter of 4 mm or more and 7 mm or less 5. The target lesion is one of the following: ? When 70%-99% occlusion, the total lesion length is more than 40mm and less than 180mm ? When angiography is 100% occluded when evaluated visually, the total lesion length is 100 mm or less ? For non-occlusive lesions containing 100% occluded segments, the completely occluded segment is 100 mm or less and the total lesion length is 40 mm or more and 180 mm or less ? If the tandem or lesion is adjacent, it can be treated as a single lesion, the distance between lesions is 30 mm or less, and the total combined lesion length including the distance between lesions is 40 mm or more and 180 mm or less 6. A person who agrees to use one or more of the clinically appropriate contraceptive methods during the trial period 7. A person who voluntarily agrees to participate in a clinical trial and is willing to follow the subject's compliance
Exclusion criteria
Exclusion criteria: 1. Stroke or ST segment elevation myocardial infarction 3 months prior to screening 2. Target lesions with acute Thrombus or Acute Aneurysm 3. Those with a history of amputation 4. When the guide wire cannot pass through the target lesion 5. Distal run-off artery is not smooth even below the ankle 6. People who are sensitive or allergic to Paclitaxel, Shellac, Vitamin E-TPGS 7. People who are allergic to or cannot take heparin, aspirin, anticoagulants, or antiplatelet drugs 8. The target lesion is any of the following: ? In stent restenotic ? In case of restenosis after drug-coated balloon procedure ? If Bypass surgery was previously performed ? Pre-dilation cannot be performed due to severe concentric calcification lesions on angiography, or it is unsuccessful and the clinical trial equipment is inadequate 9. When it is difficult to apply the clinical trial equipment because it cannot be expanded or fails to apply 10. Those who have a vascular stent that restricts blood flow to Grade D or higher after pre-expansion or needs a stent procedure 11. All major interventions (e.g., heart, peripheral, abdomen, and SFA/PA opposite the procedure) are scheduled within 30 days of the procedure 12. People with contrast agent allergies 13. A person whose life expectancy is less than one year, as determined by the investigator 14. Patients with chronic renal failure with serum creatinine greater than 2.5 mg/dL 15. Women or men planning to become pregnant 16. A person who is currently participating in another clinical trial or has participated in another clinical trial within 90 days of the screening date 17. Other, if the investigator determines that participation in the clinical trial is inappropriate because it may ethically or affect the outcome of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In segment late limit loss | — |
Secondary
| Measure | Time frame |
|---|---|
| Restenosis rate;Target lesion revascularization;Changes in Rutherford classification;Changes in Ankle-brachial index or Toe-brachial index | — |
Countries
Korea, Republic of
Contacts
Public ContactJehwan Won
Ajou University Hospital
Outcome results
None listed