Diseased Saphenous Vein GraftsSleeve IIINCT01307553
Over and Under/Aneugraft Pericardium Covered Stent Long Term Follow up Registry
An observational study of Diseased Saphenous Vein Grafts and Aneurysmal Coronary Arteries, run by ITGI Medical at 2 sites in 2 countries.
Trial summary
The purpose of this study is to track the clinical safety and effectiveness of the Pericardium Covered Stent in "real world" use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diseased Saphenous Vein Grafts, Aneurysmal Coronary Arteries
- What is being tested?
- Pericardium Covered Stent
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2010to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting for PCI.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Israel1 site, 1 recruiting
- Not yet recruiting
Sapir Health Center
Cfar Saba
Morris Mosseri, MD, morris.mosseri@clalit.org.il
United Kingdom1 site, 1 recruiting
- Recruiting
Kings College Hospital
London
Asif Qasim, MA PhD MRCP, asif@g-cardio.net
About this study
Official 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.
Read the 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.
- Being tested
- Pericardium Covered Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericardium Covered StentDevice
Also called Over and Under, Aneugraft
Percutaneous implantation of pericardium covered stent
| Study group | Role | What they receive |
|---|---|---|
| PCS Group | Not described Receives: Device: Pericardium Covered Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (Major Adverse Clinical Events)
Measured: 6 months
Secondary outcomes (2)
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
Measured: 30 days, 1 Year, 2 Years, 3 Years
Hospital readmission due to cardiac reason.
Measured: 30 days, 6 months. 1 Year, 2 Years, 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startSep 2010
- Primary completionOct 2012 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Diseased Saphenous Vein GraftsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ITGI Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Asif Qasim, Principal investigator, King's College Hospital NHS TrustMorris Mosseri, MD, Principal investigator, Sapir Health Center, Cfar Saba, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307553
- Sponsor's protocol ID
- Sleeve III
- Acronym
- Sleeve III
- Status last verified
- Mar 2011
- First submitted
- 1 Mar 2011
- Last updated
- 3 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20675659Malkin C, Gunn J. A big cover-up. Heart. 2009 Aug;95(16):1354. doi: 10.1136/hrt.2009.171843. No abstract available.
PubMed 19638513Wykrzykowska 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.
PubMed 20432403Tyczynski 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.
PubMed 20542801Jokhi 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.
PubMed 19805849Hayat 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.
PubMed 19642186Colombo 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.
PubMed 19736166Heper 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.
PubMed 16736101Gaspar 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.
PubMed 10385166Gaspar 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.
PubMed 11806031Gaspar 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.
PubMed 12623575Ferlini 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.
PubMed 21144975
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OVER AND UNDER/ANEUGRAFT PERICARDIUM COVERED STENT Long Term Follow Up Registry
- ClinicalTrials.gov ID
- NCT01307553
- Acronym / sponsor ID
- Sleeve III / Sleeve III
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- ITGI MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 3 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCS Group | – | Device: Pericardium Covered Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for PCI.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pericardium Covered StentAlso: Over and Under, AneugraftPercutaneous implantation of pericardium covered stent | Device | PCS Group |
Primary outcome
MACE (Major Adverse Clinical Events)
Time frame: 6 months
2 secondary outcomes
MACE
Time frame: 30 days, 1 Year, 2 Years, 3 Years
Hospital readmission due to cardiac reason.
Time frame: 30 days, 6 months. 1 Year, 2 Years, 3 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2011.
- Background: PubMed 20675659Siregar 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.
- Background: PubMed 19638513Malkin C, Gunn J. A big cover-up. Heart. 2009 Aug;95(16):1354. doi: 10.1136/hrt.2009.171843. No abstract available.
- Background: PubMed 20432403Wykrzykowska 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.
- Background: PubMed 20542801Tyczynski 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.
- Background: PubMed 19805849Jokhi 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.
- Background: PubMed 19642186Hayat 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.
- Background: PubMed 19736166Colombo 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.
- Background: PubMed 16736101Heper 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.
- Background: PubMed 10385166Gaspar 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.
- Background: PubMed 11806031Gaspar 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.
- Background: PubMed 12623575Gaspar 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.
- Results publication: PubMed 21144975Ferlini 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.
Related trials for Diseased Saphenous Vein Grafts
Not yet recruiting
Reconstruction of Diffusely Diseased Left Anterior Descending with Left Internal Mammary Artery On-lay Patch or Saphenous Vein Patch Without Endarterectomy by Opening the Whole Wall of the Diseased Segment(s) Has Less Risk and Fewer Complications Compared to Endarterectomy Technique
LAD (Left Anterior Descending) Coronary Artery Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asif Qasim principal investigator
King's College Hospital NHS Trust
Morris Mosseri, MD principal investigator
Sapir Health Center, Cfar Saba, Israel
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diseased Saphenous Vein Grafts and Aneurysmal Coronary Arteries, run by ITGI Medical at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Lewis, MD (+972722200338, matthewl@itgimedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (Major Adverse Clinical Events) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01307553, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2011.