Clinical Trials Logo

Clinical Trial Summary

The present post-market surveillance study aims to evaluate the safety and effectiveness of the Angio-SealTM VIP VCD in patients undergoing endovascular procedures via femoral access in real-world setting.


Clinical Trial Description

The proposed Post-Market Clinical Follow-up study is a prospective, multi-Center, observational study, aiming to further demonstrate the safety and effectiveness of the Angio-SealTM VIP VCD in achieving hemostasis of femoral artery access site in real-world subjects undergoing percutaneous endovascular procedures. 230 patients will be enrolled at up to 6 sites in Europe. Follow-ups are scheduled at 30 days (+7 days) by hospital visit or telephone call. The sponsor shall provide training and the necessary guidelines to assist each investigation site on the data collection in the eCRF. Each site is responsible to report the available data requested by the CIP. In order to ensure data quality, validation & consistency, edit checks will be designed during database development. Data Management team and the study monitors will be responsible to review the data and raise queries in the eCRF. Data cleaning will be done in regular intervals specified in DMP. The final clean standardised datasets will be available prior to database lock for data analysis. An audit trail logging all data entered and edited is available within the EDC system. All source documents are maintained in the hospital files ready for inspection by the Sponsor and regulatory authorities upon request. The Sponsor will inform the investigator of the time period for retaining these records as per applicable regulatory requirements. The study will be monitored at all stages of its development by study monitors appointed by the sponsor. Study monitors are designated as Sponsor representatives and are assigned to oversee the conduct and progress of the study at each site in accordance with the Monitoring Plan established for this clinical investigation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05335525
Study type Observational
Source Terumo Europe N.V.
Contact Evelyne Vicca
Phone +32 16 381284
Email evelyne.vicca@terumo-europe.com
Status Recruiting
Phase
Start date September 30, 2022
Completion date May 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT01903044 - Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating Phase 1/Phase 2
Completed NCT02271529 - Zilver PTX Delivery System N/A
Completed NCT02228564 - BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease N/A
Recruiting NCT02054871 - RCT to Evaluate the Renal Protective Effects of Remote Ischaemic Preconditioning in Peripheral Angioplasty N/A
Completed NCT00822172 - Evaluation of Cilostazol in Combination With L-Carnitine Phase 4
Completed NCT00574782 - Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE) N/A
Completed NCT00029991 - Extract of Ginkgo Biloba (EGB 761) and Vascular Function Phase 1/Phase 2
Completed NCT01355406 - Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System N/A
Recruiting NCT05804097 - Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently? Phase 4
Recruiting NCT03638115 - The VaSecure BTK Study N/A
Active, not recruiting NCT03241459 - Safety and Efficacy of the SurVeil™ Drug-Coated Balloon N/A
Active, not recruiting NCT01661231 - Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe N/A
Completed NCT01722877 - JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions N/A
Completed NCT01444378 - Absolute Pro® MOMENTUM™ N/A
Completed NCT00753337 - The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study N/A
Completed NCT00538226 - Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg Phase 1
Completed NCT00593385 - Atrium iCAST Iliac Stent Pivotal Study N/A
Recruiting NCT00385385 - RESTORE-IT-Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients With a History of Atherosclerotic Disease Phase 2
Completed NCT00392509 - ALD-301 for Critical Limb Ischemia, Randomized Trial Phase 1/Phase 2
Completed NCT00278603 - Stem Cell Injection for Peripheral Vascular Disease Phase 1