Clinical Trials Logo
  1. Home
  2. Ischemic Heart Disease
  3. NCT05292144
  4. Details
NCT05292144 Clinical Trial

Xperience Pro PMCF Study

Ischemic Heart Disease Clinical Trial

— rEPIC04A  

Official title:
Xperience Pro Post-Market Clinical Follow-up Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05292144
Other study ID # Xperience Pro PMCF Study
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 26, 2022
Est. completion date May 5, 2023

Study information
Verified date May 2023
Source Fundación EPIC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Xperience Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Xperience Pro .

Description:

The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Xperience Pro in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date May 5, 2023
Est. primary completion date April 26, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient treated with Xperience pro according to routine hospital practice and following instructions for use - Informed consent signed Exclusion Criteria: - Not meet inclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Xperience Pro
Patients in whom treatment with (Xperience Pro) has been attempted

Locations
Country Name City State
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitario de Getafe Getafe
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Marques de Valdecilla Santander
Spain Hospital Universitario Virgen de Valme Sevilla

Sponsors (1)
Lead Sponsor Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available. — View Citation

Kandzari DE, Teirstein PS, Kereiakes DJ, Cannon LA, Hearne SE, Kuo HC, Ying SW, Cheong WF, Popma JJ. Procedural effectiveness of a novel 1.20 mm diameter angioplasty catheter: clinical and angiographic outcomes. J Interv Cardiol. 2013 Apr;26(2):131-6. doi: 10.1111/j.1540-8183.2013.12021.x. Epub 2013 Jan 31. — View Citation

Kandzari DE, Zankar AA, Teirstein PS, Brilakis ES, Banerjee S, Price MJ, Stinis CT, Hudson PA, Dahle TG, Eng M, Brown R, Ferguson A, Addo TA, Popma JJ. Clinical outcomes following predilation with a novel 1.25-mm diameter angioplasty catheter. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):510-4. doi: 10.1002/ccd.22734. Epub 2010 Nov 4. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Safety Endpoint. Freedom from Target Lesion Failure Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction and and new Target Lesion Revascularization (TLR) 7 days
Secondary Efficacy Endpoint. Freedom from Target Lesion Failure Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and and new Target Lesion Revascularization (TLR). 7 days
Secondary Freedom from Balloon rupture Freedom from Balloon rupture During percutaneous coronary intervention (PCI)
Secondary Freedom from Hypotube rupture Freedom from Hypotube rupture During PCI
Secondary Freedom from Complicated withdrawal Freedom from Complicated withdrawal During PCI
Secondary Freedom from Coronary perforation Freedom from Coronary perforation During PCI
Secondary Freedom from Coronary dissection >C Freedom from Coronary dissection >C During PCI
Secondary Freedom from No reflow Freedom from No reflow During PCI
Secondary Freedom from Coronary thrombosis Freedom from Coronary thrombosis During PCI
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Active, not recruiting NCT04562805 - Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT) N/A
Recruiting NCT05292079 - CAPTURER PMCF Study ( rEPIC04D )
Recruiting NCT05292092 - Essential Pro PMCF Study ( rEPIC04E )
Recruiting NCT05292014 - ANGIOLITE PMCF Study ( rEPIC04F )
Recruiting NCT05292118 - Navitian PMCF Study ( rEPIC04C )
Completed NCT05292105 - NC Xperience PMCF Study( rEPIC04B)
Completed NCT03076801 - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? N/A
Not yet recruiting NCT04153383 - Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery
Recruiting NCT02729064 - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose Phase 1
Recruiting NCT02982434 - The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation Phase 2
Completed NCT02468401 - Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions N/A
Completed NCT02759406 - Evaluation of the Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System in Patients With Symptomatic Ischemic Heart Disease: A Safety and Performance Study N/A
Recruiting NCT01681381 - Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization N/A
Completed NCT01604213 - Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease Phase 4
Completed NCT01699802 - Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa) N/A
Completed NCT01334268 - RESOLUTE China RCT N/A
Completed NCT01724567 - Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training N/A
Completed NCT02159235 - Heavy Metals, Angiogenesis Factors and Osteopontin in Coronary Artery Disease (CAD) N/A