Test of Long-Term Safety and Efficacy of Sirolimus-Permanent-Polymer Eluting Stent (Cypher)- and Sirolimus-Polymer-free Eluting Stents (PPS/PFS) Assessed by Optical Coherence Tomography (PPS/PFS-OCT)
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Purpose
The objective of this pilot study is to compare the PFS-eluting stent (ISAR Rapa G1) with the PPS-eluting stent (Cypher®) regarding uncovered stent strut segments at 5 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Heart Disease |
Device: Sirolimus-Permanent-Polymer Eluting Stent Device: Sirolimus-Polymer-free Eluting Stent |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilop Trial of OCT-determined Coverage of Permanent or Polymer-free Sirolimus Eluting Stent at Long Term |
- Degree of stent strut coverage after 5 years assessed by OCT for each visible strut segment [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Percentage of malapposed strut assessed by OCT [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Percentage of uncovered malapposed struts assessed by OCT [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Morphologic differences of neointima between stents [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Late lumen loss at 5 years assessed by OCT [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
Sirolimus-Permanent-Polymer Eluting Stent
|
Device: Sirolimus-Permanent-Polymer Eluting Stent
due randomization sirolimus-permanent-polymer eluting stent was implanted
Other Name: Cypher®
|
|
Active Comparator: Arm 2
Sirolimus-Polymer-free Eluting Stent
|
Device: Sirolimus-Polymer-free Eluting Stent
due randomization sirolimus-polymer-free eluting stent was implanted
Other Name: ISAR Rapa G1
|
Detailed Description:
The mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based DES. The extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. The optical coherence tomography (OCT) is an intravascular imaging modality based on light. The principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation.
Patients who received a polymer-free or a permanent-polymer sirolimus-eluting stent about 5 years ago without in-segment intervention since, will be evaluated by OCT regarding the healing pattern and the late lumen loss of the stent.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients older than age 18 with with previous implantation of polymer-free or permanent-polymer sirolimus-eluting stents 5 years ago due to ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels.
- Written, informed consent by the patient or her/his legally-authorized representative for participation in the study and assessment by OCT.
- In women with childbearing potential a negative pregnancy test is mandatory.
Exclusion Criteria:
- Intervention in the segment of the study stent after the index procedure
- Target lesion located in the left main trunk.
- In-stent restenosis with difficulty to pass the OCT device
- Acute myocardial infarction
- Known allergy to the study medications: Sirolimus, rapamycin, probucol or stainless steel.
- Pregnancy (present, suspected or planned) or positive pregnancy test.
- Patient's inability to fully cooperate with the study protocol.
Contacts and Locations| Contact: Julinda Mehilli, MD | +49 89 12 18 ext 4582 | mehilli@dhm.mhn.de |
| Contact: Klaus Tiroch, MD | +49 89 12 18 ext 4578 | tiroch@dhm.mhn.de |
| Germany | |
| Deutsches Herzzentrum Muenchen | Recruiting |
| Munich, Bavaria, Germany, 80636 | |
| Contact: Julinda Mehilli, MD +49 89 12 18 ext 4582 mehilli@dhm.mhn.de | |
| Contact: Klaus Tiroch, MD +49 89 12 18 ext 4578 tiroch@dhm.mhn.de | |
| Klinikum rechts der Isar | Recruiting |
| Munich, Bavaria, Germany, 81675 | |
| Contact: Steffen Massberg, MD +49 89 12 18 ext 4025 massberg@dhm.mhn.de | |
| Principal Investigator: | Klaus Tiroch, MD | Deutsches Herzzentrum Muenchen |
More Information
No publications provided
| Responsible Party: | Deutsches Herzzentrum Muenchen |
| ClinicalTrials.gov Identifier: | NCT01260558 History of Changes |
| Other Study ID Numbers: | GE IDE No. S03310 |
| Study First Received: | December 14, 2010 |
| Last Updated: | May 7, 2012 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Sirolimus Everolimus |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013