Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to track the clinical safety and effectiveness of the Pericardium Covered Stent in "real world" use.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCS Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pericardium Covered Stent | Device | Percutaneous implantation of pericardium covered stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACE (Major Adverse Clinical Events) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Hospital readmission due to cardiac reason. |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients presenting for PCI.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Lewis, MD | Contact | +972722200338 | matthewl@itgimedical.com | |
| Shimon Lobel | Contact | +972722200351 | shimonl@itgimedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Asif Qasim | King's College Hospital NHS Trust | Principal Investigator |
| Morris Mosseri, MD | Sapir Health Center, Cfar Saba, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapir Health Center | Not yet recruiting | Cfar Saba | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20675659 | Background | 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. | |
| 19638513 | Background | Malkin C, Gunn J. A big cover-up. Heart. 2009 Aug;95(16):1354. doi: 10.1136/hrt.2009.171843. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 days, 6 months. 1 Year, 2 Years, 3 Years |
| Kings College Hospital | Recruiting | London | United Kingdom |
|
| 20432403 | Background | 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. |
| 20542801 | Background | 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. |
| 19805849 | Background | 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. |
| 19642186 | Background | 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. |
| 19736166 | Background | 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. |
| 16736101 | Background | 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. |
| 10385166 | Background | 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. |
| 11806031 | Background | 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. |
| 12623575 | Background | 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. |
| 21144975 | Result | 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. |