Test of Long-Term Safety and Efficacy of Sirolimus-Perman... | NCT01260558

Studies
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

NCT01260558

Sponsor

Deutsches Herzzentrum Muenchen

Status

Unknown status

Last Update Posted

May 8, 2012Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

Coronary Heart Disease

Interventions

Sirolimus-Permanent-Polymer Eluting Stent
Sirolimus-Polymer-free Eluting Stent

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Dec 14, 2010

First Submission Date that Met QC Criteria

Dec 14, 2010

First Posted Date

Dec 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2012

Last Update Posted Date

May 8, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Active Comparator	Sirolimus-Permanent-Polymer Eluting Stent	Device: Sirolimus-Permanent-Polymer Eluting Stent
Arm 2	Active Comparator	Sirolimus-Polymer-free Eluting Stent	Device: Sirolimus-Polymer-free Eluting Stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sirolimus-Permanent-Polymer Eluting Stent	Device	due randomization sirolimus-permanent-polymer eluting stent was implanted	Arm 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Julinda Mehilli, MD	Contact	+49 89 12 18	4582	mehilli@dhm.mhn.de
Klaus Tiroch, MD	Contact	+49 89 12 18	4578	tiroch@dhm.mhn.de

Overall Officials

Name	Affiliation	Role
Klaus Tiroch, MD	Deutsches Herzzentrum Muenchen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deutsches Herzzentrum Muenchen	Recruiting	Munich	Bavaria	80636	Germany

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases