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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01610102




Registration number
NCT01610102
Ethics application status
Date submitted
30/05/2012
Date registered
1/06/2012
Date last updated
5/02/2015

Titles & IDs
Public title
PROGRESS-AMS 1.0 Clinical Long Term Follow-Up
Scientific title
Clinical Performance and Angiographic Results of Coronary Stenting With Absorbable Metal Stents, Clinical Long Term Follow-Up
Secondary ID [1] 0 0
C1104
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long Term Safety of the AMS 1.0 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Target Lesion Failure (TLF)
Timepoint [1] 0 0
up to 7 years follow-up

Eligibility
Key inclusion criteria
- Signed informed consent form available prior to clinical long term follow-up
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patent did not sign the informed consent form prior to clinical long term follow-up

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin & Repatriation Medical Centre - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalst
Country [2] 0 0
Germany
State/province [2] 0 0
NRW
Country [3] 0 0
Netherlands
State/province [3] 0 0
Eindhoven
Country [4] 0 0
Switzerland
State/province [4] 0 0
Luzern
Country [5] 0 0
Switzerland
State/province [5] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biotronik AG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to collect long term clinical follow-up data on all
patients enrolled in the PROGRESS AMS-1.0 study to assess long term safety of the AMS-1.0
Trial website
https://clinicaltrials.gov/ct2/show/NCT01610102
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Raimund Erbel, Prof.
Address 0 0
Westdeutsches Herzzentrum Essen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01610102