Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02254356
  4. Details
NCT02254356 Clinical Trial

Zilver Flex Post-Market Study in Japan

Peripheral Arterial Disease (PAD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02254356
Other study ID # 12-005-FLX
Secondary ID
Status Completed
Phase N/A
First received September 29, 2014
Last updated March 29, 2018
Start date May 2012
Est. completion date December 26, 2017

Study information
Verified date March 2018
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 Flex device.

Recruitment information / eligibility
Status Completed
Enrollment 239
Est. completion date December 26, 2017
Est. primary completion date December 26, 2017
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

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Zilver Flex Bare Metal Stent

Locations
Country Name City State
Japan Fukuoka Sanno Hospital Fukuoka

Sponsors (1)
Lead Sponsor Collaborator
Cook Group Incorporated

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of stent fracture 3 years
Primary Rate of adverse events 3 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 NCT02254837 - Zilver PTX 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