CAPTURER PMCF Study ( rEPIC04D )

Ischemic Heart Disease Clinical Trial

— rEPIC04D  

Official title:

CAPTURER PMCF Post-Market Clinical Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05292079
• Other study ID #: CAPTURER PMCF Study
• Status: Recruiting
• Start date: September 29, 2022
• Est. completion date: March 30, 2025

Study information

• Verified date: January 2023
• Source: Fundación EPIC
• Contact: FUNDACION EPIC
• Phone: 987225638
• Email: iepic[@]fundacionepic.org
• Is FDA regulated: No
• 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 CAPTURER to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with CAPTURER .

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 CAPTURER 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: Recruiting
• Enrollment: 85
• Est. completion date: March 30, 2025
• Est. primary completion date: March 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient treated with CAPTURER according to routine hospital practice and following instructions for use
• Informed consent signed

Exclusion Criteria:

• Not meet inclusion criteria

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Spain	H. Puerta Del Mar	Cadiz
Spain	Hospital de San Pedro	Logroño
Spain	Hospital Universitario Regional de Malaga	Málaga
Spain	Hospital Universitario Virgen de La Victoria	Málaga
Spain	Hospital Clinico Universitario de Santiago de Compostela	Santiago De Compostela

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Chevalier B, Gilard M, Lang I, Commeau P, Roosen J, Hanssen M, Lefevre T, Carrie D, Bartorelli A, Montalescot G, Parikh K. Systematic primary aspiration in acute myocardial percutaneous intervention: a multicentre randomised controlled trial of the export aspiration catheter. EuroIntervention. 2008 Aug;4(2):222-8. doi: 10.4244/eijv4i2a40. — View Citation

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

Sardella G, Mancone M, Bucciarelli-Ducci C, Agati L, Scardala R, Carbone I, Francone M, Di Roma A, Benedetti G, Conti G, Fedele F. Thrombus aspiration during primary percutaneous coronary intervention improves myocardial reperfusion and reduces infarct size: the EXPIRA (thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention) prospective, randomized trial. J Am Coll Cardiol. 2009 Jan 27;53(4):309-15. doi: 10.1016/j.jacc.2008.10.017. — View Citation

Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med. 2008 Feb 7;358(6):557-67. doi: 10.1056/NEJMoa0706416. — 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 end point of cardiac death, myocardial infarction, stroke and and new Target Lesion Revascularization (TLR)	30 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)	30 days
Secondary	Freedom from Device rupture	Freedom from Device rupture	During percutaneous coronary intervention (PCI)
Secondary	Freedom from Kinking	Freedom from Kinking	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