Clinical trial NCT01307553: Over and Under/Aneugraft Pericardium Covered Stent Long Term Follow up Registry
Official title: OVER AND UNDER/ANEUGRAFT PERICARDIUM COVERED STENT Long Term Follow Up Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diseased Saphenous Vein Grafts
Aneurysmal Coronary Arteries
Lead sponsor: ITGI Medical
Sponsor class: INDUSTRY
First posted: 2011-03-03
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for PCI.

Brief summary: The purpose of this study is to track the clinical safety and effectiveness of the Pericardium Covered Stent in "real world" use.

Detailed description: This is a multi-center registry of 75 patients treated with the Over and Under/Aneugraft Pericardium Covered Stent (PCS) (IGTI, Israel). The registry will involve the collection of demographic, clinical, and angiographic data on the treated patient population, including in-hospital, 30 day, 6-month, 1 year, 2 years and 3 years clinical follow-up data.

Eligibility criteria: 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

Primary outcomes:
measure: MACE (Major Adverse Clinical Events)
timeFrame: 6 months
Secondary outcomes:
measure: MACE
timeFrame: 30 days, 1 Year, 2 Years, 3 Years
measure: Hospital readmission due to cardiac reason.
timeFrame: 30 days, 6 months. 1 Year, 2 Years, 3 Years
Other outcomes:
Locations:
city: Cfar Saba
country: Israel
facility: Sapir Health Center
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: King's College Hospital NHS Trust
name: Asif Qasim
role: PRINCIPAL_INVESTIGATOR
affiliation: Sapir Health Center, Cfar Saba, Israel
name: Morris Mosseri, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
citation: Malkin C, Gunn J. A big cover-up. Heart. 2009 Aug;95(16):1354. doi: 10.1136/hrt.2009.171843. No abstract available.
citation: 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.
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.
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.
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.
citation: 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.
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. doi: 10.1007/s00270-005-0149-2.
citation: 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.
citation: 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.
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. doi: 10.1080/acc.2.4.241.246.
citation: 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.