Acute Coronary Syndrome Clinical Trial
Official title:
ISAR-DESIRE 4: Randomized Trial Of Scoring Balloon in Patients With Restenosis in "Limus"-Eluting Coronary Stents Undergoing Angioplasty With Paclitaxel-Coated Balloon
The purpose of the study is to determine whether scoring balloon (SCB) plus paclitaxel-coated balloon (PCB) is superior to PCB alone for the treatment of restenosis within "limus"-eluting stents (LES)
The optimal treatment of in-BMS-restenosis seems to be implantation of a DES which is
supported by a large body of evidence. Nevertheless, several recent published studies have
shown a substantial reduction in late lumen loss and angiographic restenosis using
paclitaxel-coated balloons (PCB) for restenotic lesions. Given the increased world-wide use
of DES and the use of DES in increasingly complex coronary disease patterns, the number of
patients presenting with restenosis after DES implantation will further increase in the
coming decade.
Data regarding the optimal treatment of in-DES-restenosis are very limited: Implanting a new
DES for in-DES-restenosis has been reported to associate with repeat restenosis rates as
high as 20%. In addition, an increased risk of stent thrombosis has been associated with
complex stenting and with additional DES implantation. Thus, for lesions which develop
restenosis after LES implantation, the optimal treatment strategy remains unknown.
Few results on small sample-size populations have been reported in patients treated with
scoring or cutting balloon (SCB) technology for treatment of BMS restenosis as compared to
plain balloon angioplasty. Moreover, the efficacy of SCB angioplasty in DES restenosis has
not been adequately addressed. Furthermore, the potential additive benefit of SCB
angioplasty in patients undergoing PCB therapy remains to be elucidated. The hypothesis
behind this concept is that the application of SCB prior to deployment of PCB may increase
the bioavailability of paclitaxel within the restenotic tissue, and therefore may increase
the efficacy of PCB. There are numerous preclinical studies to support this hypothesis,
which show that lesion preparation is an important pre-requisite for the effectiveness of
PCB.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
| Recruiting |
NCT06013813 -
Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI
|
N/A | |
| Recruiting |
NCT05412927 -
AngelMed Guardian® System PMA Post Approval Study
|
||
| Completed |
NCT02750579 -
Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes?
|
N/A | |
| Completed |
NCT04102410 -
Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients
|
N/A | |
| Enrolling by invitation |
NCT03342131 -
Serum Concentration of Wnt2 and Wnt4 in Patients With Acute Coronary Syndrome
|
N/A | |
| Recruiting |
NCT01218776 -
International Survey of Acute Coronary Syndromes in Transitional Countries
|
||
| Enrolling by invitation |
NCT04676100 -
International CR Registry
|
||
| Completed |
NCT03590535 -
5th Generation cTnT in ED ACS
|
||
| Recruiting |
NCT05437900 -
INSIGHTFUL-FFR Clinical Trial
|
Phase 4 | |
| Completed |
NCT05551429 -
Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
|
||
| Terminated |
NCT04316481 -
IDE-ALERTS Continued Access Study
|
N/A | |
| Active, not recruiting |
NCT04475380 -
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
|
||
| Not yet recruiting |
NCT04852146 -
Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine.
|
||
| Active, not recruiting |
NCT02892903 -
In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes?
|
N/A | |
| Not yet recruiting |
NCT02871622 -
BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM
|
N/A | |
| Completed |
NCT04077229 -
Piloting Text Messages to Promote Positive Affect and Physical Activity
|
N/A | |
| Completed |
NCT02944123 -
Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR)
|
Phase 3 | |
| Active, not recruiting |
NCT02922140 -
The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit
|
N/A | |
| Completed |
NCT02673437 -
Rivaroxaban ACS Specialist Cohort Event Monitoring Study
|