Comparison of the PrimAry Long Versus Short Coverage With Drug-Eluting Stents for Long FemoRopopliteal Artery DiseasE (PARADE II): Investigator-initiated Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2021-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

* Prospective, randomized, controlled, multi-center study
* A total of 220 subjects with long femoropopliteal lesions will be included according to inclusion and exclusion criteria.
* Patients will be randomized in a 1:1 manner into long stenting group versus short stenting group. and treated with Zilver PTX for long femoropopliteal lesions
* Patients will be followed clinically for 1 year after the procedure.
* Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Zilver® PTX™ Global Registry

NCT01094678

Peripheral Arterial Disease Peripheral Vascular Disease

COMPLETED NA

Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex

NCT05296031

Vascular Diseases

COMPLETED NA

Zilver PTX Drug-Eluting Peripheral Stent Study

NCT01348425

Peripheral Arterial Disease

COMPLETED NA

BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions

NCT02004951

Peripheral Arterial Disease Femoropopliteal Lesions

TERMINATED NA

Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease

NCT02701543

Peripheral Artery Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Femoropopliteal Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Long stenting group

Group Type EXPERIMENTAL

Long stenting using drug-eluting stent (Zilver PTX)

Intervention Type DEVICE

Long stenting by full coverage of long femoropopliteal lesion with Zilver PTX after balloon angioplasty

Short stenting group

Group Type ACTIVE_COMPARATOR

Spot stenting using drug-eluting stent (Zilver PTX)

Intervention Type DEVICE

Spot stenting by coverage of residual stenosis or flow-limiting dissection with Zilver PTX after balloon angioplasty of long femoropopliteal lesion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Long stenting using drug-eluting stent (Zilver PTX)

Long stenting by full coverage of long femoropopliteal lesion with Zilver PTX after balloon angioplasty

Intervention Type DEVICE

Spot stenting using drug-eluting stent (Zilver PTX)

Spot stenting by coverage of residual stenosis or flow-limiting dissection with Zilver PTX after balloon angioplasty of long femoropopliteal lesion

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical criteria:

1. Age 19 years of older
2. Symptomatic peripheral artery disease:

1. Moderate or severe claudication (Rutherford category 2 or 3)
2. Critical limb ischemia (Rutherford category 4 or 5)
3. Patients with signed informed consent
* Anatomical criteria:

1. Target lesion length ≥150 mm by angiographic estimation
2. Stenosis of more than 50% in femoropopliteal artery
3. At least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel.

Exclusion Criteria

* A. Clinical criteria

1. Acute critical limb ischemia
2. Severe critical limb ischemia (Rutherford category 6)
3. Major bleeding history within prior 2 months
4. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agents
5. Age \> 85 years
6. Severe hepatic dysfunction (\> 3 times normal reference values)
7. Significant renal dysfunction (Serum creatinine \> 2.0 mg/dl
8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
9. LVEF(left ventricular ejection fraction) \<40% or clinically overt congestive heart failure
10. Pregnant women or women with potential childbearing
11. Life expectancy \<1 year due to comorbidity
* Angiographic criteria

1. Previous bypass surgery or stenting of the superficial femoral artery
2. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50%stenosis or or occlusion
3. Popliteal artery stenosis \>50% at P2 or P3 segment

Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No