Coronary Restenosis Clinical Trial
Official title:
Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons
The PACCOCATH ISR study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis.
Background: Drug-eluting stents have shown promising anti-restenotic effects in clinical trials. It may be preferable, however, to avoid the stent-in-stent approach in treating in-stent restenosis (ISR). In prior animal trials, we demonstrated a highly significant reduction of neointimal formation by drug-eluting balloon catheters (DEB). The aim of the PACCOCATH ISR study is to investigate the novel DEB in the treatment of ISR. Methods and results: The PACCOCATH ISR study is a randomized, double-blind German multicenter trial on the efficacy and tolerance of the DEB in coronary ISR. Patients are randomized to rePTCA of ISR either using the coated PTCA balloon (3 µg paclitaxel/mm² balloon surface) or a non-coated balloon of the same type (n=52 patients). Balloon inflation time is 60 seconds in both cases. Major inclusion criteria are an ISR in a coronary artery with a diameter stenosis of at least 70%, < 25 mm length, and a vessel diameter of 2.5 to 3.5 mm. The primary endpoint is late lumen loss after 6 months (independent angiographic core lab). Secondary endpoints are binary restenosis rate and major adverse cardiac events. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01205776 -
EXCEL Clinical Trial
|
N/A | |
| Active, not recruiting |
NCT04475380 -
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
|
||
| Completed |
NCT02263313 -
EGO-COMBO Clinical End-point Extension Study Beyond 36 Months
|
N/A | |
| Completed |
NCT00248066 -
Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary Arteries
|
Phase 2 | |
| Completed |
NCT00148356 -
Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT02508714 -
Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents
|
N/A | |
| Completed |
NCT01274234 -
OCT Evaluation of Healing of COMBO Stent
|
Phase 1/Phase 2 | |
| Completed |
NCT01205789 -
EXCEL Clinical Trial (Universal Registry)
|
N/A | |
| Recruiting |
NCT00426049 -
Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation
|
Phase 3 | |
| Terminated |
NCT00243308 -
Serp-1 for the Treatment of Acute Coronary Syndrome
|
Phase 2 | |
| Completed |
NCT00180466 -
PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions
|
N/A | |
| Completed |
NCT00859183 -
Oral Sirolimus for In-Stent Restenosis
|
Phase 4 | |
| Completed |
NCT03667313 -
Treatment of In-Stent Restenosis 2 Study
|
Phase 3 | |
| Recruiting |
NCT05089864 -
STAR and Deferred Stenting Study
|
N/A | |
| Active, not recruiting |
NCT02175706 -
DUrable Polymer-based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity
|
N/A | |
| Completed |
NCT01249027 -
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
|
||
| Completed |
NCT01331707 -
DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population
|
Phase 4 | |
| Recruiting |
NCT00500279 -
Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial
|
Phase 4 | |
| Completed |
NCT00402272 -
SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
|
Phase 4 | |
| Completed |
NCT01171820 -
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
|
Phase 4 |