Thunder Trial - Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The Thunder Trail is a randomized , double-blinded, placebo controlled German multi-centre study on the efficacy of local paclitaxel for prevention of restenosis in the superficial and popliteal artery.
| Condition | Intervention | Phase |
|---|---|---|
|
Arterial Occlusive Diseases |
Drug: Balloon Angioplasty with or without drug administration |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder – Trial) |
- Late lumen loss of vessel segment following dilatation after 6 months
- Thrombotic complications or revascularization of the target vessel, death; adverse reactions known to occur after paclitaxel (high dose tumor therapy except reactions to the detergent)
- Paclitaxel plasma concentration will be determined immediately after administration
| Estimated Enrollment: | 135 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | October 2007 |
Drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries. Unfortunately drug eluting stents failed to demonstrate superiority over bare stents in the superficial femoral artery. We could show that a non-stent based delivery of Taxan was equal or superior to drug eluting stents in an animal model. This was both true for the coronary arteries and peripheral vessels.
In a prospective blinded trail >135 patients are randomized either to receive Taxan locally administered with a balloon catheter during balloon angioplasty, or together with contrast media. One group serves as control. There were no limitations due to lesion length. Follow-up angiography will be after 6 months, 12 months and 2 years.
Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults
- Chronic Occlusions and stenosis (history at least 6 weeks) ≥70 % diameter Stenosis > 2cm in the arteria femoralis superficialis or arteria poplitea
- Various criteria assuring ethical issues and follow up
Exclusion Criteria:
- Conditions requiring different treatment or raising serious safety concern regarding the procedure or the required medication.
- Pregnancy can not be excluded
- Doubts in the willingness or capability of the patient to allow 6 months follow up
Contacts and Locations| Germany | |
| University Hospital of Tuebingen | |
| Tuebingen, Germany, 72076 | |
| Principal Investigator: | Gunnar Tepe, MD | University Hospital of Tuebingen |
| Principal Investigator: | Gunnar Tepe, MD | University Hospital Tuebingen |
More Information
No publications provided by University Hospital Tuebingen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00156624 History of Changes |
| Other Study ID Numbers: | Pac-2 |
| Study First Received: | September 7, 2005 |
| Last Updated: | April 24, 2006 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University Hospital Tuebingen:
|
Intervention Peripheral Vascular Disease Drug Restenosis 18 years and above |
Additional relevant MeSH terms:
|
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013