Aneurysmal Coronary Arteries Clinical Trial
— Sleeve IIIOfficial title:
OVER AND UNDER/ANEUGRAFT PERICARDIUM COVERED STENT Long Term Follow Up Registry
The purpose of this study is to track the clinical safety and effectiveness of the Pericardium Covered Stent in "real world" use.
| Status | Recruiting |
| Enrollment | 75 |
| Est. completion date | April 2015 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patient is older than 18 years - Patient must be available for follow-up - Patient must be fully informed, provided with the patient information sheet and sign the Informed Consent Form prior to the procedure. - The lesion to be treated should be suitable for treatment with a PCS in that: - A. A suitable length and diameter PCS should be available - B. For SVG disease a single or multiple PCS may be used - C. For native coronary artery aneurysms the operator should be confident that the aneurysm may be excluded by the implantation of a single PCS Exclusion Criteria: - Significant co-morbidity precluding clinical follow-up. - Pregnancy; pregnancy test negative in women with child bearing potential - Acute ST-elevation myocardial infarction within the preceding 48 hours - Previous stent implantation in the target vessel - Left main coronary artery disease - Contra-indication to dual anti-platelet therapy. - Planned surgery which will lead to discontinuation of antiplatelet therapy - Thrombocytopenia (<100,000/mm3) - Ejection fraction <30%. - Renal failure (creatinine >180 µmol/L [2 mg/dL]) - Prior brachytherapy - Recipient of heart transplant - Acute infections |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Sapir Health Center | Cfar Saba | |
| United Kingdom | Kings College Hospital | London |
| Lead Sponsor | Collaborator |
|---|---|
| ITGI Medical |
Israel, United Kingdom,
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Ferlini M, Russo F, Marinoni B, Repetto A, Canosi U, Ferrario M, Visconti LO, Bramucci E. Images in cardiology. Percutaneous coronary aneurysm obliteration using a novel pericardium-covered stent. J Am Coll Cardiol. 2010 Dec 14;56(25):2139. doi: 10.1016/j — View Citation
Gaspar J, Martínez-Ríos MA, Vonderwalde C, Rosas M, Ban-Hayashi E, Eidt-Lidt G, Kuri J. Pericardium-covered stent for septal myocardial ablation in hypertrophic obstructive cardiomyopathy. Catheter Cardiovasc Interv. 1999 May;47(1):73-9. — View Citation
Gaspar J, Vonderwalde C, Eid-Lidt G. Treatment of coronary artery aneurysms by percutaneous sealing with bovine-pericardium-covered stents. Int J Cardiovasc Intervent. 1999;2(4):241-246. — View Citation
Gaspar J, Vonderwalde C, Hong MK, Eid-Lidt G, Almagor Y, León MB. [Stent coated with bovine pericardium: in vitro evaluation, in animals, and initial results in humans]. Arch Cardiol Mex. 2001 Oct-Dec;71(4):286-94. Spanish. — View Citation
Hayat SA, Ghani S, More RS. Treatment of ruptured coronary aneurysm with a novel covered stent. Catheter Cardiovasc Interv. 2009 Aug 1;74(2):367-70. doi: 10.1002/ccd.21937. — View Citation
Heper G, Barcin C, Iyisoy A, Tore HF. Treatment of an iatrogenic left internal mammary artery to pulmonary artery fistula with a bovine pericardium covered stent. Cardiovasc Intervent Radiol. 2006 Sep-Oct;29(5):879-82. — View Citation
Jokhi PP, McKenzie DB, O'Kane P. Use of a novel pericardial covered stent to seal an iatrogenic coronary perforation. J Invasive Cardiol. 2009 Oct;21(10):E187-90. — View Citation
Malkin C, Gunn J. A big cover-up. Heart. 2009 Aug;95(16):1354. doi: 10.1136/hrt.2009.171843. — View Citation
Siregar S, Hoseyni Guyomi S, van Herwerden LA. Covered stents in giant coronary artery aneurysm. Eur Heart J. 2010 Nov;31(22):2823. doi: 10.1093/eurheartj/ehq267. Epub 2010 Jul 30. — View Citation
Tyczynski P, Kukreja N, van Geuns RJ, Wykrzykowska JJ, Sheppard MN, Di Mario C. Optical coherence tomography for the assessment of pericardium covered stents for the treatment of degenerated saphenous vein grafts. EuroIntervention. 2010 May;6(1):78-85. doi: 10.4244/. — View Citation
Wykrzykowska JJ, Gutiérrez-Chico JL, van Geuns RJ. "Over-and-under" pericardial covered stent with paclitaxel balloon in a saphenous vein graft. Catheter Cardiovasc Interv. 2010 May 1;75(6):964-6. doi: 10.1002/ccd.22412. — View Citation
* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | MACE (Major Adverse Clinical Events) | 6 months | Yes | |
| Secondary | MACE | MACE is a composite end point of cardiac death, myocardial infarction and target vessel revascularisation (TVR). Each one of the MACE components will be recorded separately |
30 days, 1 Year, 2 Years, 3 Years | Yes |
| Secondary | Hospital readmission due to cardiac reason. | 30 days, 6 months. 1 Year, 2 Years, 3 Years | Yes |