Peripheral Arterial Disase (PAD) is a disease that causes numbness, pain, ulcer, and necrosis due to poor blood flow due to narrowing of blood vessels in the lower extremities. About 29 percent of patients aged 50 to 70 or older suffer from smoking or diabetes. peripheral arterial disease is reported to be caused by increased life expectancy and increased incidence of diabetes, and to treat it, lifestyle correction, drug therapy, bypass, endotomy, and endotrophic surgery (PTA) are being performed.
One of the many approaches has been used as a standard treatment to date as it has been shown to significantly reduce the incidence of post-treatment vascularization (Revasculature) in a way that has been developed to allow the drug to release from the application area after coating the drug with a drug-eluting stent (DES). However, it is reported that there is a high probability of re-sealing due to the reduction of elasticity of the transplanted blood vessels and the restriction of repeated procedures and the formation of the neonate, and that stent thrombosis and chronic inflammation occur, so it is necessary to develop a product that can accurately localize the lesion without stent transplantation and restore the normal endometrium. Thus, a very simple form of drug-coated balloon (DCB) catheter was developed to apply the drug to the surface of the balloon catheter and deliver the drug to the application area, and was intended to limit the re-stabbing or occlusion of the blood vessels after the procedure.
Drug-coated balloon catheters (DCB) and drug-eluting stents (DES) differ in many ways, even if they use the same active pharmacological ingredient (API, [Ex.] Paclitelax). DES is obtained immediately after the inflation of the balloon, whereas the drug purchased in the polymer is slowly released over time and the maximum drug level in the tissue reaches only a few days or weeks after transplantation. DCB is also known to have drug coatings spread quickly and completely from the device during the development of the balloon catter, but the process of tissue absorption of Paclitaxel is complex because of the fact that Paclitaxel is extremely friendly, and if Paclitaxel itself is a form that is coated with a balloon, it will not be released quickly through the balloon's surface only for a short period of time.
The purpose of this clinical trial is to obtain a drug-coated vascular system for patients with peripheral arterial diseases (SFA) and De novo or non-stent retraction (Non-stent restenotic) lesions* of the Supernatural femoral artery (PA).We want to demonstrate meanness and evaluate safety compared to 'IN.PACT Admiral DCB'.

Treatment

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 1:1 and applied once at the time of the procedure.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Use of control group(IN.PACT Admiral DCB) for patients with peripheral artery disease

Arm Label

Target Number of Participant

Arm Type

Arm Description

Use of test group(Genoss DCB) for patients with peripheral artery disease

Gender

Age

Description

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:
 ① When 70%-99% occlusion, the total lesion length is more than 40mm and less than 180mm
 ② When angiography is 100% occluded when evaluated visually, the total lesion length is 100 mm or less
 ③ 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
 ④ 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

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:
 ① In stent restenotic
 ② In case of restenosis after drug-coated balloon procedure
 ③ If Bypass surgery was previously performed
 ④ 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.

In segment late limit loss

6 months after the procedure

Restenosis rate

6 months after the procedure

Target lesion revascularization

1 month, 6 months, 12 months after the procedure

Changes in Rutherford classification

1 month, 6 months, 12 months after the procedure

Changes in Ankle-brachial index or Toe-brachial index

1 month, 6 months, 12 months after the procedure