ROCCSTAR Trial - randomisation of calcified coronary stenosis to taxus stenting with or without rational atherectomy
| ISRCTN | ISRCTN11538874 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11538874 |
| Protocol serial number | N0185139370 |
| Sponsor | Department of Health |
| Funder | Plymouth Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 10/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J G Motwani
Scientific
Scientific
Cardiology Department
Level 06
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom
| Phone | +44 (0)1752 763560 |
|---|---|
| joseph.motwani@phnt.swest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | ROCCSTAR Trial - randomisation of calcified coronary stenosis to taxus stenting with or without rational atherectomy |
| Study objectives | Is Rotastenting better, worse or equal to drug eluting stent alone? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Cardiovascular |
| Intervention | Randomise consented and eligible patients to the two treatments and follow up at 30 days and 8 months |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
8 month follow up health |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 120 |
| Total final enrolment | 119 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 07/11/2003 |
| Date of final enrolment | 01/06/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cardiology Department
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | effectiveness of rotational atherectomy | 01/03/2000 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/11/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
