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)

Pilop Trial of OCT-determined Coverage of Permanent or Polymer-free Sirolimus Eluting Stent at Long Term

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Device: Sirolimus-Permanent-Polymer Eluting Stent; Device: Sirolimus-Polymer-free Eluting Stent

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Recruiting
      • Klinikum rechts der Isar
      • Contact: Steffen Massberg, MD; Phone Number: 4025 +49 89 12 18; Email: massberg@dhm.mhn.de
    • Munich, Bavaria, Germany, 80636
      • Recruiting
      • Deutsches Herzzentrum Muenchen
      • Contact: Julinda Mehilli, MD; Phone Number: 4582 +49 89 12 18; Email: mehilli@dhm.mhn.de
      • Contact: Klaus Tiroch, MD; Phone Number: 4578 +49 89 12 18; Email: tiroch@dhm.mhn.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: ISAR Rapa G1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Degree of stent strut coverage after 5 years assessed by OCT for each visible strut segment	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of malapposed strut assessed by OCT	5 years
Percentage of uncovered malapposed struts assessed by OCT	5 years
Morphologic differences of neointima between stents	5 years
Late lumen loss at 5 years assessed by OCT	5 years

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Investigators: Principal Investigator: Klaus Tiroch, MD, Deutsches Herzzentrum Muenchen

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: December 14, 2010
• First Posted (Estimate): December 15, 2010

Study Record Updates

• Last Update Posted (Estimate): May 8, 2012
• Last Update Submitted That Met QC Criteria: May 7, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: GE IDE No. S03310