Peripheral Arterial Disease
Conditions
Brief summary
Disrupt PAD Japan is a prospective, multi-center, single-arm study of SWM-831 to treat moderate and severely calcified femoropopliteal arteries, prior to DCB or stenting.
Detailed description
Up to 60 subjects at up to 10 sites in Japan will be enrolled in the femoropopliteal clinical study with moderate and severely calcified femoropopliteal artery disease presenting with Rutherford Category 2 - 5 of the target limb. Two additional cohorts \[Iliac and BTK (Below-the-Knee)\] will enroll a minimum of 10 and a maximum of 15 subjects each with moderate and severely calcified iliac disease with a Rutherford Category (RC) 2 - 5 and a minimum of 10 and a maximum of 15 subjects with moderate and severely calcified BTK lesions with a Rutherford Category (RC) 2 - 5 will be enrolled and followed through 12 months. The estimated study duration for these cohorts is approximately 24 months. Study subjects will be followed through discharge, 30 days, 6, and 12 months.
Interventions
DEVICEPeripheral Intravascular Lithotripsy (IVL)
For the Disrupt PAD Japan study, the Shockwave Medical Peripheral IVL System (SWM-831) is intended for lithotripsy enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the femoropopliteal arteries.
Sponsors
Iqvia Pty Ltd
Massachusetts General Hospital
Yale University
Shockwave Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The objective of the study is to assess the safety and effectiveness of IVL to treat moderate and severely calcified femoropopliteal arteries, prior to DCB or stenting.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: Subjects are required to meet all of the following inclusion criteria in order to be enrolled in the clinical study: 1. Subject is able and willing to comply with all assessments in the study. 2. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form. 3. Age of subject is ≥ 18. Note: If a subject is under 20 years, voluntary agreement shall be obtained from both the subject and the subject's representative or legal guardian using the written consent form. 4. Rutherford Clinical Category 2, 3, 4, or 5 of the target limb. 5. Estimated life expectancy \> 1 year. Angiographic Inclusion Criteria: Subjects are required to meet all of the following inclusion criteria in order to be enrolled in the clinical study. For lesion characteristics, each target lesion must meet eligibility. 1. One target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery). \<Not applicable to iliac or BTK cohort\> 2. Target lesion reference vessel diameter (RVD) is between 4.0 mm and 8.0 mm by investigator visual estimate. \<Not applicable to iliac or BTK cohort\> 3. Target lesion with ≥ 70% stenosis by investigator visual estimate. 4. Target lesion length is ≤ 200 mm by investigator visual estimate. Target lesion can be all or part of the 200 mm treated zone. 5. Subject has at least one patent tibial vessel on the target limb with runoff to the foot, defined as no stenosis ≥ 50%. 6. Calcification is determined to be grade 2 - 4 (unilateral calcification ≥ 5 cm, bilateral wall calcification \< 5 cm, and bilateral calcification ≥ 5 cm, respectively), as defined by PACSS (Peripheral Artery Calcification Scoring System). \<Not applicable to iliac and BTK cohort\> Angiographic Inclusion Criteria specific to Iliac Arteries 1. Target lesion located in the native, de novo common or external iliac artery. 2. Target lesion reference vessel diameter (RVD) is between 5.0 mm and 10.0 mm by investigator visual estimate. 3. Evidence of PACSS calcification grade 2 - 4 and non-dilatable lesion indicating presence of calcium. Note: Non-dilatable lesion requires attempted treatment with PTA during the index procedure with residual stenosis ≥ 50% and no serious angiographic complication. Angiographic Inclusion Criteria specific to BTK Arteries 1. Target lesion from the native, de novo distal segment of the popliteal artery to the ankle joint. 2. Target lesion reference vessel diameter (RVD) is between 2.0 mm and 4.0 mm by investigator visual estimate. 3. Evidence of PACSS calcification grade 2 - 4 and non-dilatable lesion indicating presence of calcium. Note: Non-dilatable lesion requires attempted treatment with PTA during the index procedure with residual stenosis ≥ 50% and no serious angiographic complication. General
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects with Procedural Success | Day 0 | Primary Endpoint for Femoropopliteal: Procedural success is defined as residual stenosis \< 50% without ≥ grade D dissections, prior to Drug-Coated Balloon (DCB) or stenting for the treated target lesion (core lab assessed) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual stenosis < 50% without ≥ grade D dissections | Day 0 | Femoropopliteal Technical Success defined as residual stenosis \< 50% without ≥ grade D dissections (core lab assessed) at the final timepoint (after DCB or stenting). |
| Residual stenosis < 30% without ≥ grade D dissections | Day 0 | Femoropopliteal Technical Success defined as residual stenosis \< 30% without ≥ grade D dissections (core lab assessed) at the final timepoint (after DCB or stenting) |
| Number of participants with freedom from clinically-driven target lesion revascularization (CD-TLR) CEC adjudicated and freedom from restenosis as determined by duplex-derived peak systolic velocity ratio (PSVR) ≤ 2.4, assessed by the DUS core lab. | At 6 months and 12 months post-procedure | Primary patency at 6 and 12 months defined as freedom from clinically-driven target lesion revascularization (CD-TLR) CEC adjudicated and freedom from restenosis as determined by duplex-derived peak systolic velocity ratio (PSVR) ≤ 2.4, assessed by the DUS core lab. \- CD-TLR is defined as any revascularization (endovascular or surgical) within the target vessel due to symptoms or drop of ABI \> 20% or \> 0.15 when compared to the 30-day ABI and associated with an angiographic lesion ≥ 50% at the target lesion site. |
| Rate of ≥ grade D dissections, perforation, distal embolization, slow flow or acute vessel closure | Day 0 | Serious angiographic complications defined as the rate of ≥ grade D dissections, perforation, distal embolization, slow flow or acute vessel closure at the final procedural timepoint, as assessed by the angiographic core lab. |
| Number of participants with change in Ankle brachial index (ABI) or Toe brachial index (TBI) | At 30 days, 6 months, and 12 months post-procedure | Ankle brachial index (ABI) or Toe brachial index (TBI) at 30 days, 6, and 12 months reported as change from baseline |
| Number of participants with change in Rutherford Category | At 30 days, 6 months, and 12 months post-procedure | Rutherford Category at 30 days, 6, 12 months reported as change from baseline |
| Number of participants with Major Adverse Event | At 30 days, 6 months and 12 months post-procedure | Major Adverse Event (MAE) at 30 days, 6 and 12 months Clinical Events Committee adjudicated (as a composite and individual components), defined as: \- Cardiovascular death \- Clinically-driven target lesion revascularization (CD-TLR) \- Unplanned target limb major amputation (above the ankle) |
Countries
Japan
Outcome results
None listed