Peripheral Vascular Disease
Conditions
Brief summary
A prospective, multicenter, randomized study evaluating the use of Jetstream Atherectomy (JS) followed by DCB in comparison to the use of plain old balloon angioplasty (POBA) followed by DCB alone in the treatment of complex lesions in femoropopliteal arteries in subjects with claudication (Rutherford Clinical Category (RCC) of 2-4) (complex lesions are defined as long (≥ 10 cm) lesions, or moderately or highly calcified lesions, or chronic total occlusions irrespective of length).
Interventions
DEVICEJetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm
Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm
Sponsors
Midwest Cardiovascular Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
255 subjects are planned for enrollment (with a block 2:1 randomization)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subject must meet all of the following general inclusion criteria. 1. Has a Rutherford Clinical Category of 2 - 4. 2. Is willing and capable of complying with all follow-up evaluations at the specified times (including an angiogram at the 1-year follow-up visit). 3. Is ≥ 18 years old. 4. Is able and willing to provide written informed consent prior to study specific procedures. Angiographic Inclusion Criteria: Subject must meet all of the following angiographic inclusion criteria. Unless otherwise specified, the Investigator performing the procedure bases all angiographic inclusion criteria on visual determination at the time of the procedure. 1. Has evidence at the target lesion of ≥ 70% de novo stenosis of a. ≥ 10 cm length, or b. any chronic total occlusion (\> 1 month by history or known by conventional or CT angiography or arterial duplex ultrasound) in the SFA (at least 1 cm from the bifurcation of the profunda) and/or popliteal artery, or 3. at least grade 2 or higher calcification as defined by the peripheral arterial calcium scoring system (PACCS)26 2. Has evidence of at least one runoff vessel to the ankle/foot of the limb to be treated that does not have significant (\< 70%) stenosis during the index procedure. 3. Has a reference vessel diameter of 4 - 7 mm. 4. Has a target lesion an exchangeable guidewire can cross via the true lumen (without using a re-entry device or a subintimal approach). General
Exclusion criteria
The subject must not meet any of the following general
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Revascularization | 1 year | Effectiveness: Target Lesion Revascularization at 1 Year: TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 1 year. For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered meeting a TLR endpoint. (ITT analysis) |
| Major Adverse Events | 30 Days | Safety: Major Adverse Events (MAE) at 30 days: unplanned amputation, total mortality or TLR at 30 days (TLR includes bail out stenting) |
Countries
United States
Contacts
STUDY_DIRECTORNicolas Shammas, MD, Research Director
MCRF
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 71.5 years STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 16 |
| other Total, other adverse events | 2 / 31 | 1 / 16 |
| serious Total, serious adverse events | 0 / 31 | 8 / 16 |
Outcome results
None listed