ANGIOLITE PMCF Study ( rEPIC04F )

Ischemic Heart Disease Clinical Trial

— rEPIC04F  

Official title:

ANGIOLITE Post-Market Clinical Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05292014
• Other study ID #: ANGIOLITE PMCF Study
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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