Over and Under/Aneugraft Pericardium Covered Stent Long Term Follow up Registry
NCT ID: NCT01307553
Last Updated: 2011-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
75 participants
OBSERVATIONAL
2010-09-30
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PCS Group
Pericardium Covered Stent
Percutaneous implantation of pericardium covered stent
Interventions
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Pericardium Covered Stent
Percutaneous implantation of pericardium covered stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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ITGI Medical
INDUSTRY
Responsible Party
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ITGI Medical
Principal Investigators
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Asif Qasim
Role: PRINCIPAL_INVESTIGATOR
King's College Hospital NHS Trust
Morris Mosseri, MD
Role: PRINCIPAL_INVESTIGATOR
Sapir Health Center, Cfar Saba, Israel
Locations
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Sapir Health Center
Cfar Saba, , Israel
Kings College Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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. No abstract available.
Malkin C, Gunn J. A big cover-up. Heart. 2009 Aug;95(16):1354. doi: 10.1136/hrt.2009.171843. No abstract available.
Wykrzykowska JJ, Gutierrez-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.
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.
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.
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.
Colombo A, Almagor Y, Gaspar J, Vonderwalde C. The pericardium covered stent (PCS). EuroIntervention. 2009 Aug;5(3):394-9. doi: 10.4244/v5i3a61. No abstract available.
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. doi: 10.1007/s00270-005-0149-2.
Gaspar J, Martinez-Rios 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. doi: 10.1002/(SICI)1522-726X(199905)47:13.0.CO;2-Z.
Gaspar J, Vonderwalde C, Hong MK, Eid-Lidt G, Almagor Y, Leon 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.
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. doi: 10.1080/acc.2.4.241.246.
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.jacc.2010.04.071. No abstract available.
Other Identifiers
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Sleeve III
Identifier Type: -
Identifier Source: org_study_id
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