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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05292079
Other study ID # CAPTURER PMCF Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
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 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

Study Design


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
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