Trials / Completed
CompletedNCT03487432
A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions
A ComparIson of Strategies to Prepare Severely Calcified Coronary Lesions - A Prospective Randomized Controlled Trial of Super High-Pressure NC PTCA Balloon Versus Scoring PTCA Balloon in Severely Calcified Coronary Lesions
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- Deutsches Herzzentrum Muenchen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pressure NC PTCA Balloon (OPN NC) or a Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty in an angiographically well-defined group of patients with severely calcified coronary lesions (grade 3) undergoing coronary stent implantation (SYNERGY everolimus-eluting stent (EES)).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Super High-Pressure NC PTCA Balloon (OPN NC) | Strategy of Super High-Pressure NC PTCA Balloon (OPN NC) after unsuccessful lesion preparation with conventional NC balloon angioplasty. |
| DEVICE | Scoring PTCA Balloon (NSE Alpha) | Strategy of Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty. |
Timeline
- Start date
- 2018-07-20
- Primary completion
- 2019-09-23
- Completion
- 2019-10-23
- First posted
- 2018-04-04
- Last updated
- 2019-11-22
Locations
5 sites across 2 countries: Germany, Switzerland
Source: ClinicalTrials.gov record NCT03487432. Inclusion in this directory is not an endorsement.