Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02254837
  4. Details
NCT02254837 Clinical Trial

Zilver PTX Post-Market Study in Japan

Peripheral Arterial Disease (PAD) Clinical Trial

Official title:
Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02254837
Other study ID # 12-005-PTX
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2012
Est. completion date June 30, 2018

Study information
Verified date July 2019
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Japanese post market clinical study of the Zilver PTX device.

Recruitment information / eligibility
Status Completed
Enrollment 909
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Zilver PTX Drug-Eluting Stent

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cook Group Incorporated

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of stent fracture 5 years
Primary Rate of adverse events 5 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT01175850 - Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease N/A
Active, not recruiting NCT00707876 - Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD) Phase 2
Completed NCT00760565 - A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD). Phase 1
Recruiting NCT04631848 - ULTRASCORE™ Focused Force PTA Balloon Angioplasty for CLI Patients With Below the Knee Vessel Disease
Completed NCT00196066 - Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS) Phase 2
Recruiting NCT05834673 - VICTORION-ASCERTAIN: Implementation Study (v-ASCERTAIN) Phase 4
Recruiting NCT05498740 - Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia N/A
Completed NCT02780349 - Evaluation of WIRION™ EPS in Lower Extremities Arteries N/A
Completed NCT02254356 - Zilver Flex Post-Market Study in Japan N/A
Completed NCT00689377 - Prevalence of Peripheral Arterial Disease in Subject With a Moderate Risk of Cardiovascular (CV) Disease (CVD) in Primary Prevention N/A
Active, not recruiting NCT05149664 - A Non-significant Risk Clinical Study: Changes in Perfusion After Therapeutic Ultrasound in Patients With PAD N/A
Recruiting NCT04749732 - Home-based Exercise Therapy for Patients With PAD N/A
Completed NCT02936622 - Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses N/A
Completed NCT00827619 - Zilver® Flex™ Vascular Stent Study N/A
Completed NCT00862420 - Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease Phase 3
Completed NCT04753372 - Rivaroxaban Plus Aspirin in Patients With Chronic Coronary Syndrome and High Ischemic Risk
Not yet recruiting NCT06457685 - Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial N/A
Recruiting NCT05246410 - A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries. N/A
Terminated NCT03111238 - The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM Phase 3
Terminated NCT03174522 - The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM Phase 3