MDK-1901 Clinical Study

JRCT ID: jRCT1080225338

Registered date:24/08/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Peripheral Artery Disease
• Date of first enrollment: 15/07/2020
• Target sample size: 132
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : Drug Coated Balloon Dilatation Catheter
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Single use medical device

control material(s)
Generic name etc : Historical Control
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

safety
efficacy
Primary patency rate of the target lesion at 12 months after the index procedure

Secondary Outcome

safety
efficacy
<Efficacy>
(1)Technological Success: Success of insertion, dilatation, contraction, and recovery of the investigational device
(2)Procedural Success: Residual stenosis not greater than 30% of the target lesion, as visual observation of angiographic findings after dilatation with the investigational device
(3)Clinical Success: Success of the index procedure where MAE does not occur within 24 hours after the index procedure
(4)Primary patency rates at 30 days, 6 months, 24 months, and 36 months after the index procedure
(5)Assessment of 30 days, 6 months, 12 months, 24 months, and 36 months after the index procedure in the following items
1)TLR
Clinically driven-TLR
All TLRs
2)Change in Rutherford classification from baseline
3)Change in resting ABI value from baseline
4)Change in Walking Impairment Questionnaire (WIQ) scores from baseline

<Safety>
(1)Incidence of MAE and each event constituting MAE at 30 days, 6 months, 12 months, 24 months, and 36 months after the index procedure
(2)Death related to the investigational device or the index procedure at 30 days, 6 months, 12 months, 24 months, and 36 months after the index procedure
(3)Assessment of 30 days, 6 months, 12 months, 24 months, and 36 months after the index procedure in the following items
1)Clinically driven-TVR
2)Thrombosis in the target lesion
(4)Adverse events
(5)Device malfunction

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria are included.
<General Inclusion Criteria>
(1)Patients aged 20 years or older.
(2)Patients with written informed consent.
(3)Patients willing to cooperate with all protocol-specified follow-up assessments.
(4)Patients with peripheral arterial disease (PAD) with the target lesion ranging from superficial femoral artery (SFA) to popliteal artery (PA).
(5)Patients with Rutherford classification of 2-4.

< Inclusion Criteria Based On Angiography>
(1)Patients requiring PTA peripheral revascularization.
(2)Patients with stenosis or occlusion of 20 cm or less in the target lesion length.
If patients have multiple target lesions, patients whose total lesion length including between lesions is 20 cm or less and whose interval between lesions constituting multiple target lesions are 3 cm or less.
(3)Patients whose the target lesion begins 1 cm or more below the common femoral artery (CFA) bifurcation and terminate 1 cm or more above the origin of the Tibial-Peroneal Trunk, and whose the target vessel is an autologous vessel.
(4)Patients with new or restenotic lesions with visible stenosis rate of 70% or more. *1
*1 If the target lesion is restenotic lesion, at least 30 days must have elapsed since the previous angioplasty. In addition, only balloon catheters corresponding to the general type (standard and special types), anti-slipping type, and cutting type should be used.
(5)Patients with the target vessel diameter of 3.0 mm or more and 7.0 mm or less.
(6)Patients whose inflow artery was patent (<50% stenosis visually) on angiography. *2
*2 The confirmation of the patency of inflow artery could be done with other procedures than angiography. Before enrollment, treatment required to ensure access to the inflow artery lesion and the target lesion is allowed (excluding DES or DCB). If there are no major vascular complications in the inflow arterial lesion after treatment and the residual stenosis rate is 30% or less visually, enrollment in this study is allowed.
(7)Patients with one or more patent native outflow arteries to the ankle (stenosis rate of less than 50% visually) confirmed by angiography.*3
*3 No prior revascularization of the outflow artery and no planned treatment of the lesion.

Exclude criteria

Patients who meet any of the following criteria are excluded.
<General Exclusion Criteria>
(1)Pregnant women, women planning to become pregnant, or men intending to father children.
(2)Patients with a life expectancy of 3 years or less.
(3)Patients who are currently participating in other clinical studies or who were previously enrolled in this study.
(4)Patients who have experienced or are experiencing hemorrhagic stroke within 3 months before the index procedure.
(5)Patients who have undergone operation (surgery, endovascular treatment, etc.) that may affect the evaluation of this study within 15 days before the index procedure, or who are scheduled to undergo operation (surgery, endovascular treatment, etc.) within 30 days after the index procedure.
(6)Patients with a history of treatment with DCB or DES on blood vessels in the lower limbs*
* Exclude if previous treatment history cannot be followed.
(7)Patients who have received myocardial infarction or angina pectoris (in a condition requiring PCI) within 30 days before the index procedure.
(8)Patients who have received thrombolytic therapy within 30 days before the index procedure.
(9)Patients with severe renal failure. (GFR no greater than 30 mL/min) or patients undergoing dialysis.
(10)Patients who have undergone vascular surgery on the superficial femoral artery (SFA) or popliteal artery (PA) of the target limb for treatment of atherosclerosis.
(11)Patients with drug-induced hypersensitivity syndrome or contraindications to anticoagulation/antiplatelet therapy, sirolimus (or similar drugs) required for this study, or those with an allergy to contrast media that cannot be adequately pretreated prior to the index procedure.
(12)Other patients who were judged as ineligible for this study by the physician.

<Angiographic Exclusion Criteria>
(1)Patients with stents placed within 2 cm before and after the target lesion.
(2)Patients with clinically significant aneurysm disease in the iliac, femoral, popliteal, or abdominal aorta.
* The confirmation of the patency of inflow artery could be done with other procedures than angiography.
(3)Patients with acute or subacute thrombosis in the target vessel.
(4)Patients deemed to require early recoil, immediate lesion treatment, or stent placement after pre-dilatation.
(5)Patients with residual stenotic lesions of 50% or more and grade D or more according to NHLBI classification after pre-dilatation.
(6)Patients requiring adjunctive therapy (e.g., laser, atherectomy, Cryoplasty, scoring/cutting balloon).
(7)Patients with severe calcification in the target lesion (grade 3 or 4 in the calcification definition) and difficulty in dilating the target lesion.
(8)Those who cannot appropriately receive the angiography.

Related Information

• Primary Sponsor: MedAlliance Japan KK.
• Secondary Sponsor: -
• Source(s) of Monetary Support: MedAlliance Japan KK.
• Secondary ID(s): JapicCTI-205434