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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05292014
Other study ID # ANGIOLITE PMCF Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 26, 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 Angiolite sirolimus eluting stent to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Angiolite sirolimus eluting stent.


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 Angiolite Sirolimus Eluting Stent 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: - Patients treated with ANGIOLITE according to routine hospital practice and following instructions for use - Informed consent signed Exclusion Criteria: • Not meet inclusion criteria

Study Design


Intervention

Device:
ANGIOLITE
Patients in whom treatment with ANGIOLITE has been attempted

Locations

Country Name City State
Spain Hospital Clinic de Barcelona Barcelona
Spain H. Puerta Del Mar Cadiz
Spain Hospital Universitario de Leon León
Spain Hospital Universitario Virgen de La Victoria Málaga
Spain Hospital Universitario Marques de Valdecilla Santander
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 (7)

Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802. — 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

Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843. — View Citation

Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801. — View Citation

Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201. — View Citation

Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock SJ, Mehran R, Leon MB. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007 Mar 8;356(10):998-1008. doi: 10.1056/NEJMoa067193. Epub 2007 Feb 12. — View Citation

Wu X, Li L, He L. Drug-Coated Balloon versus Drug-Eluting Stent in Patients with Small-Vessel Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials. Cardiol Res Pract. 2021 Apr 13;2021:1647635. doi: 10.1155/2021/1647635. eCollection 2021. — 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, stent thrombosis (Academic Research Consortium definitive/ probable), and new Target Lesion Revascularization (TLR) 7 days
Secondary Efficacy Endpoint. Freedom fromTarget Lesion Failure Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR). 7 days
Secondary Freedom from Accidental dislodgement of the stent Freedom from Accidental dislodgement of the stent During percutaneous coronary intervention (PCI)
Secondary Freedom from Balloon rupture Freedom from Balloon rupture During 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
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